Supervisor III, Production

Engineering Supervisor

Product Manager

Director, Engineering Services

Manager, Operations

Materials Planning Supervisor

Quality Engineering Supervisor

Business Process Manager – Supply Chain Management

Deputy Team Lead (VP1/2) – KYC / CDD / AML

Site Investigation Lead, Quality Assurance

Responsibilities: <ul><li>Supervise and lead production team members across assigned shifts and production lines.</li><li>Ensure daily production schedules are met in compliance with safety, quality, and delivery requirements.</li><li>Monitor key performance indicators (OEE, yield, scrap, downtime) and implement corrective actions as needed.</li><li>Drive continuous improvement initiatives in productivity, cost reduction, and process efficiency.</li><li>Partner with Manufacturing Engineering, Quality, and Maintenance teams to resolve process and equipment issues.</li><li>Provide training, coaching, and performance feedback to team members to build skill and capability.</li><li>Enforce compliance with EHS standards, company policies, and 5S/lean manufacturing practices.</li><li>Ensure proper manpower planning, shift scheduling, and attendance management.</li><li>Manage production documentation, reporting, and escalation of issues to management.</li><li>Support new product introduction (NPI) and ensure smooth handover to mass production.</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree/diploma in Manufacturing, Mechanical, Industrial Engineering, or related field.</li><li>Minimum 5–7 years of production experience in high-volume manufacturing, with at least 3+ years in a supervisory/lead role.</li><li>Strong knowledge of lean manufacturing principles, problem-solving, and root cause analysis.</li><li>Good understanding of ISO/IATF 16949, EHS, and quality management systems.</li><li>Proven leadership, people management, and conflict resolution skills.</li><li>Ability to work in a fast-paced, 24/7 manufacturing environment with flexibility to support multiple shifts.</li></ul>

Role Description: <ul><li>The Engineering Supervisor leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new sterile injectable manufacturing site.</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through CMMS system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate or bachelor’s degree in engineering, Facilities Management, Industrial Technology, or related field (or equivalent experience).</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience in controlled substance and high potent product environment desired.</li></ul> Skills/Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

Responsibilities: <ul><li>Managing portfolio of vulcanized gates, spare gates and kit plates for IDM/OEMs- accommodate the project managers during the stage-gate-process in front of supervisory board meetings, provide documentation and business case background for selected customer projects Improve Costs and process</li><li>Lead the development and implementation of a comprehensive global strategy for managing the obsolescence of elastomers across global organisation</li><li>Supervising all changes regarding supply chain, manufacturing and assembly processes and preparing documentation for customer relevant changes</li><li>Supporting BU GSE and Sales Team with regards to all technical &amp; commercial &amp; operational aspects of gates (product data sheets, product presentation etc.)</li><li>Forecast sales objectives and ensure they are fulfilled by the business development PMs.</li><li>Managing profitability targets for the dedicated gates&nbsp;</li><li>Support other team members (OEM PMs, supply-chain management/project management) throughout the whole process of logistics, delivery, to ensure full customer satisfaction. (after the project acceptance has been confirmed by the customer, operations departments will take responsibility)</li><li>Technical customer documentation like manuals, product data sheets according to European machinery directive for kit plates, gates</li></ul> Requirements: <ul><li>Bachelor/master’s degree in mechanical engineering or related field, preferably chemical engineering&nbsp;</li><li>Experience 8-12 years</li><li>Background or experience in material sciences, preferably within the elastomer &amp; polymer field&nbsp;</li><li>Knowledge and experience in vacuum technology</li><li>Written &amp; verbal communication in German, Mandarin, Japanese or Korean besides English language (added advantage).</li><li>Experience in developing new product and service solutions in a high-tech environment.</li><li>Developing concepts and solutions for the delivery of service products engaging engineering and operations.</li><li>Driving the promotion and roll-out of new products.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.</li><li>Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.</li><li>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

Responsibilities: <ul><li>Manage the organizations inventory levels in the region from both value and coverage (Days on Hand - DoH) perspectives.</li><li>Oversee the management of imported components with the team.</li><li>Define inventory strategies aligned with the organization’s objectives.</li><li>Monitor the weekly forecast, quarterly inventory closing for the region, and allocation by stock type (finished goods, purchased, manufactured, in transit, etc.)</li><li>Monitor and define actions for the elimination of obsolete inventory.</li><li>Support monthly S&amp;OP cycles, actively participating in all phases.</li><li>Support planning activities for new projects (new sales and/or locations) and end-of-life projects.</li><li>Monitor supplier delivery performance and collaborate with the Procurement team regarding underperforming suppliers.</li><li>Periodically review SKU consumption profiles with the team and adjust replenishment policies when necessary.</li><li>Support planners in cases of delivery and/or production delays.</li><li>Manage special freight requests, assess root causes, and support actions to prevent recurrence.</li><li>Ensure strong integration and collaboration of the team with other departments, especially other teams within the Supply Chain function.</li><li>Provide periodic feedback to the team, highlighting strengths and guiding improvements.</li><li>Encourage and develop the teams pursuit/implementation of process improvements and best practices in planning.</li><li>Adapt planning strategies to the specific needs of each business unit served.</li><li>Seek and apply new market trends and best practices to company processes.</li><li>Establish and monitor individual and team performance indicators, coordinating actions to meet targets.</li><li>Monitor and ensure resolution of pending issues.</li></ul>&nbsp;Requirements: Preferred Years of Experience / Minimum Qualifications: <ul><li>Bachelor’s degree in Production Engineering, Business Administration, Logistics, or related fields.</li><li>Postgraduate degree in the area is desirable.</li><li>Previous experience managing material planning teams.</li><li>Previous experience in the automotive industry.</li></ul> Required Skills: <ul><li>Knowledge of imported component management and S&amp;OP processes.</li><li>Advanced English for conversation.</li><li>Knowledge of SAP (PP and MM modules).</li><li>Proficiency in Microsoft Office Suite.</li><li>Availability to work on-site in Bragança Paulista, SP – Brazil.</li></ul>

Responsibilities: <ul><li>Lead a team of customer-facing quality engineers to provide root cause analysis and corrective action communications to our customers during quality issues within our target timeframes.</li><li>Utilize formal problem-solving techniques to resolve product and process-related issues, leading cross-functional teams.</li><li>Lead cross-functional Notice of Escape teams to ensure containment, root cause analysis, corrective action, and communication to customers.</li><li>Evaluate customer requirements during order processing, drive implementation of new customer-specific requirements, and negotiate requirements not in the best interest of the company.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Review and approve First Article reports.</li><li>Work cross-functionally to disposition nonconforming product found at incoming, in process, or returned from customers and approve any deviations required.</li><li>Support direct reports through coaching, development, and prioritization of responsibilities. Hold direct reports accountable for results and task completion.</li></ul> Requirements: <ul><li>Bachelor’s Degree required in a related field such as Engineering, Quality, or Reliability Engineering.</li><li>7+ years of industry experience, including 2+ years supervising others.</li><li>Up to 10% travel may be required, including international travel.</li><li>Excellent presentation skills, along with strong written and verbal communication skills.</li><li>Must possess strong problem-solving skills. Advanced problem-solving tools such as Lean Six Sigma Green Belt or Shainin Red X Journeyman are a plus.</li><li>Excellent negotiation skills both internally and externally to drive completion of 8D documents that advance the organization toward world-class manufacturing.</li><li>Experience leading problem-solving teams and using tools such as 8D, 5-Why Analysis, and Fishbone Diagrams.</li><li>Working knowledge of quality systems in an ISO9001/AS9100 environment is a plus.</li><li>Strong computer skills, including proficiency in SAP, Microsoft Word, Excel, and PowerPoint.</li></ul>

Responsibilities: <ul><li>Managing portfolio of vulcanized gates, spare gates and kit plates for IDM/OEMs- accommodate the project managers during the stage-gate-process in front of supervisory board meetings, provide documentation and business case background for selected customer projects Improve Costs and process</li><li>Lead the development and implementation of a comprehensive global strategy for managing the obsolescence of elastomers across global organisation</li><li>Supervising all changes regarding supply chain, manufacturing and assembly processes and preparing documentation for customer relevant changes</li><li>Supporting BU GSE and Sales Team with regards to all technical &amp; commercial &amp; operational aspects of gates (product data sheets, product presentation etc.)</li><li>Forecast sales objectives and ensure they are fulfilled by the business development PMs.</li><li>Managing profitability targets for the dedicated gates&nbsp;</li><li>Support other team members (OEM PMs, supply-chain management/project management) throughout the whole process of logistics, delivery, to ensure full customer satisfaction. (after the project acceptance has been confirmed by the customer, operations departments will take responsibility)</li><li>Technical customer documentation like manuals, product data sheets according to European machinery directive for kit plates, gates</li></ul> Requirements: <ul><li>Bachelor/master’s degree in mechanical engineering or related field, preferably chemical engineering&nbsp;</li><li>Background or experience in material sciences, preferably within the elastomer &amp; polymer field&nbsp;</li><li>Knowledge and experience in vacuum technology</li><li>Written &amp; verbal communication in German, Mandarin, Japanese or Korean besides English language (added advantage).</li><li>Experience in developing new product and service solutions in a high-tech environment.</li><li>Developing concepts and solutions for the delivery</li></ul>

Responsibilities: <ul><li>Support the Team Manager in undertaking joint ownership, accountability, and execution in overall AML CDD strategic program for the customer segments within Group Wholesale Banking&nbsp;</li><li>Consistently review &amp; work with key stakeholders to enhance work processes to achieve operations efficiency while ensuring consistent interpretation and implementation of Group Compliance AML/CFT policies and framework&nbsp;</li><li>Revise and update local SOP and workflow processes for operational efficiency and effectiveness&nbsp;</li><li>Conduct AFC related training to the team&nbsp;</li><li>Escalate and highlight potential concerns / risks and proactively share best risk management practices&nbsp;</li><li>Ensure agreed SLAs supported by the teams are met&nbsp;</li><li>Responsible for checking and signing off complex and high-risk customers due diligence profiles for all jurisdictions&nbsp;</li><li>Work with Group AFC Ops function to manage queries during External / Internal Audit, Group Compliance and Regulatory Audit for favourable review outcomes&nbsp;</li><li>Support and work with the KYC teams performing CDD fulfillment to meet with Bank and Regulatory requirements pertaining to customer’s life cycle with the Bank.&nbsp;</li><li>Focus on procedures and processes to enable the KYC teams to achieve monthly satisfactory score for Key Operational Risk Indicator (KORI) metrics&nbsp;</li><li>Provide oversight and steer to ensure alignment of bank’s management responsibility and principles for effective risk and controls and connectivity across the teams and with Group AFC Ops&nbsp;</li><li>Support Group AFC Ops in FACTCA and CRS reporting matters&nbsp;</li></ul> Requirements: <ul><li>At least 8 years of relevant experience in KYC / CDD.</li><li>A track record in risk and regulatory matters pertaining to know your customer (KYC) and financial crimes risks and typologies in ensuring customer due diligence is executed appropriately, with a clear thought process, rather than a tick box exercise&nbsp;</li><li>Experienced in analyzing and quantifying issues tied to AML CDD / transactions / activities surveillance.&nbsp;</li><li>To demonstrate relevant experience in the management of people and relationships via supervisory experiences.&nbsp;</li><li>Together with the Group AFC Ops (where applicable), support to advise senior stakeholders with a level of confidence, knowledge, and stature in the handling of customers’ due diligence requirements&nbsp;</li><li>Align thinking and behaviours that are in tandem with the Bank’s commitment against financial crimes, with the highest level of integrity and the ability to balance commercial objectives with the exercise of independent and prudent judgement&nbsp;</li><li>Certification as an AML specialist (e.g., CAMS / Diploma in AML) with a recognized institution will be an advantage</li><li>Proficient in Mandarin is an added advantage</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Skills

Industry

Location

Jobtitle

14 supervisory Jobs found

Supervisor III, Production

Engineering Supervisor

Product Manager

Director, Engineering Services

Manager, Operations

Materials Planning Supervisor

Quality Engineering Supervisor

Business Process Manager – Supply Chain Management

Deputy Team Lead (VP1/2) – KYC / CDD / AML

Site Investigation Lead, Quality Assurance

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

14 supervisory Jobs found

Supervisor III, Production

Engineering Supervisor

Product Manager

Director, Engineering Services

Manager, Operations

Materials Planning Supervisor

Quality Engineering Supervisor

Business Process Manager – Supply Chain Management

Deputy Team Lead (VP1/2) – KYC / CDD / AML

Site Investigation Lead, Quality Assurance

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.