Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

EHS Manager

Facilities Technician

Sales Manager - Emergency Lighting and Fire Alarm & Detection Systems

Senior Manager - Portfolio Development

Warehouse Technician

General Accounting Lead

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities:&nbsp; <ul><li>Train and develop team members to foster a culture of continuous improvement and operational excellence.</li><li>Be accountable of site production teams’ engagement.</li><li>Follow up site production team capabilities and create a multi functional environment.</li><li>Lead and coordinate daily production activities to meet production targets, quality standards, and delivery deadlines.</li><li>Develop and implement process improvements using continuous improvement methodologies.</li><li>Analyze production data to identify areas for efficiency gains and waste reduction.</li><li>Collaborate with cross-functional teams (engineering, quality, supply chain) to resolve production issues.</li><li>Monitor key performance indicators (KPIs) related to production efficiency, waste, safety, and quality.</li><li>Ensure compliance with safety regulations and promote a safe working environment.</li><li>Manage resources effectively, including workforce planning and equipment utilization.</li><li>Prepare reports on production.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering</li><li>Minimum 10 years of experience in production management, continuous improvement, or operational efficiency roles.</li><li>Strong expertise in Lean Manufacturing, TPM, WCM, IWS or other process improvement methodologies</li><li>Excellent analytical and problem-solving skills, with proficiency in data-driven decision-making.</li><li>Experience in the tobacco or FMCG industry is highly desirable.</li><li>Strong leadership abilities to drive change and influence teams across different levels of the organization.</li><li>Ability to manage multiple projects efficiently in a fast-paced environment.</li><li>Additional support activities as assigned.</li></ul>

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

Responsibilities: EHS Strategy &amp; Leadership: <ul><li>Develop, implement, and maintain a comprehensive EHS management system aligned with company goals and regulatory requirements.&nbsp;</li><li>Integrate EHS strategy into broader business planning and participate in leadership meetings to influence decision-making.&nbsp;</li><li>Lead change management initiatives to build a proactive safety culture across all levels of the organization.</li></ul> Risk Management &amp; Compliance: <ul><li>Conduct and advise on risk assessments, quantify and prioritize risks, and implement effective control measures.&nbsp;</li><li>Ensure compliance with OSHA, EPA, and other relevant local, state, and federal regulations.&nbsp;</li><li>Oversee contractor and visitor safety programs, including onboarding and compliance tracking.</li></ul> Training &amp; Engagement: <ul><li>Design and deliver engaging EHS training programs tailored to various roles and risk profiles.&nbsp;</li><li>Promote employee engagement through behavior-based safety (BBS), ergonomics, and wellness initiatives.&nbsp;</li><li>Champion inclusive safety practices that consider diverse employee needs and backgrounds.</li><li>Emergency Preparedness &amp; Crisis Management: Develop and maintain emergency response plans, conduct drills, and coordinate with local emergency services.&nbsp;</li><li>Lead crisis management efforts, including communication protocols and post-incident reviews.</li></ul> Environmental Sustainability: <ul><li>Implement and monitor environmental sustainability programs, including waste reduction, energy efficiency, and water conservation.</li><li>Audits, Inspections &amp; Continuous Improvement: Conduct regular audits and inspections to identify hazards and ensure compliance.&nbsp;</li><li>Use data analytics and digital tools to track performance, identify trends, and drive continuous improvement.</li><li>Hazardous Materials &amp; Waste Management: Oversee safe handling, storage, and disposal of hazardous chemicals and waste.&nbsp;</li><li>Ensure proper documentation and training related to chemical safety and spill containment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Safety, Industrial Engineering, or related field</li><li>7+ years’ experience, including 2+ years of progressive people management experience - (equivalent experience may be considered).</li><li>Proven experience in chemical handling, technical operations, and regulatory compliance.</li><li>Strong knowledge of OSHA, EPA, ISO standards, and other applicable regulations.</li><li>Proficiency in EHS software platforms and data analytics tools. Demonstrated leadership, communication, and team-building skills.</li><li>Ability to manage projects, influence cross-functional teams, and drive cultural transformation.</li></ul>

Responsibilities: <ul><li>Oversee day-to-day facility operations including HVAC systems (WCPU), air compressors, air dryers, sewage treatment systems, and general building maintenance with work at height compliance.</li><li>Provide hands-on support for: - Cooling tower infill services - Split unit A/C maintenance - Compressed Dry Air (CDA) piping installation - A compressor piping - New production line setup including electrical wiring</li><li>Supervise the infrastructure, ensuring safe and efficient operation in accordance with Malaysian electrical codes.</li><li>Manage and execute facility installation projects, expansions, and upgrades in line with production needs.</li><li>Ensure adherence to safety protocols, environmental regulations, and industry standards.</li><li>Collaborate with production, quality, and engineering teams to align facility operations with manufacturing targets.</li><li>Handle vendor management and oversee service contracts for equipment maintenance and utilities.</li><li>Perform routine troubleshooting and preventive maintenance, minimizing downtime and enhancing productivity.</li><li>Maintain detailed documentation, reports, and Preventive Maintenance (PM) records.</li></ul> Requirements: <ul><li>Minimum 3 years of experience in facility management within a manufacturing environment, preferably in antenna, electronics, or cable assembly industries.</li><li>Solid hands-on expertise in: - HVAC systems - Air compressors - CDA piping and A compressor piping - Electrical and mechanical facility systems</li><li>Familiar with energy efficiency practices, sustainability initiatives, and lean manufacturing principles.</li><li>Strong problem-solving skills and the ability to work independently in a fast-paced production setting.</li></ul>

Role Description: <ul><li>This role is responsible for driving business development within the Life Safety market across France, Morocco, Italy and Austria.</li><li>The Sales Manager will define and execute the sales strategy, identify new business opportunities, and build strong relationships with both new and existing customers. Close collaboration with the local sales organizations, along with direct account management, will be essential to support revenue growth.&nbsp;</li><li>The position covers the following countries: France, Morocco, Italy and Austria.&nbsp;</li><li>This role reports to the Business Development Leader – Life Safety Division, EMEA &amp; APAC.&nbsp;</li></ul> Responsibilities: <ul><li>Own and drive sales growth and full profit plan execution, managing the process end-to-end in collaboration with the Country Sales Organizations (CSOs).&nbsp;</li><li>Define and implement strategic initiatives and business development plans to support growth, staying up to date on industry trends, competitive activity, and market dynamics, while working closely with the country sales organizations.&nbsp;</li><li>Develop and expand existing customer accounts by promoting the full Life Safety portfolio, building strong relationships with key decision-makers, understanding their needs, and delivering tailored solutions. Focus particularly on Tier 1/Tier 2&nbsp;</li><li>large-scale projects including Digital, Connected, and Cybersecurity applications.&nbsp;</li><li>Identify and pursue new business opportunities across the assigned region, leveraging both the Fire Alarm and Emergency Lighting product portfolios.&nbsp;</li><li>Strengthen market presence through active customer engagement, including meetings, events, and partnership development.&nbsp;</li><li>Collaborate closely with product line managers, marketing and operational teams to align on sales targets and support the strategic initiatives.&nbsp;</li><li>Implement and manage pricing strategies in coordination with customers and Country Sales Organizations (CSOs).&nbsp;</li><li>Adopt and apply companys standard processes and tools, such as Salesforce and CRM-based pipeline management.&nbsp;</li><li>Travel within the assigned region, with a minimum quarterly frequency, to support customer engagement and business development activities.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Engineering Degree or similar;&nbsp;</li><li>10+ years exp in commercial Life Safety market or similar.&nbsp;</li></ul> Skills:&nbsp; <ul><li>Commercial experience managing large customers (specifically Life Safety distributors and systems integrators);&nbsp;</li><li>Good working knowledge of Life Safety technical solutions &amp; standards&nbsp;</li><li>Proven track record of customer engagement / satisfaction;&nbsp;</li><li>Analytical thinking, ethical at all times;&nbsp;</li><li>Interpersonal and influencing / negotiating skills, ability to coordinate&nbsp;</li><li>Excellent verbal and written communication in English and French;&nbsp;</li><li>Work well within a team environment, whilst being able to plan and execute own work initiatives;&nbsp;</li><li>Strong presentation skills.&nbsp;</li></ul> What We Offer:&nbsp; <ul><li>Competitive compensation and benefits package;&nbsp;</li><li>Flexible working solution;&nbsp;</li><li>Challenging projects in dynamic collaborative team in an international environment;&nbsp;</li><li>We care about Inclusion and diversity, and we care about you– in our organization we have several initiatives celebrating diversity and making our daily life more inclusive;&nbsp;</li><li>We make your aspirations matter – our organization encourages internal promotion, whenever possible;&nbsp;</li><li>We make your wellbeing matter – we offer Health Insurance Plan and a&nbsp;</li><li>Company Welfare Plan for all Employees;&nbsp;</li><li>We make your growth matter – we invest in our employee for the long term with annual performance &amp; Development reviews;&nbsp;</li><li>We make your contributions matter - reliability, safety, efficiency, and sustainability are at the core of our dedication to improving people’s lives and the environment through power management technologies.&nbsp;</li></ul>

Key Responsibilities: Global Portfolio Strategy <ul><li>Define and implement a unified global portfolio vision to meet future consumer/customer needs for filters and beyond filters (combustibles and next generation products)</li><li>Direct multi category program and project management to ensure innovation efforts are focused towards building a healthy portfolio</li><li>Balance global consistency with regional customization to maximize market relevance and profitability.</li><li>Oversee portfolio lifecycle management, including launches, rationalization, and category transitions.</li></ul>&nbsp;Market &amp; Consumer Insights <ul><li>Lead global research initiatives to capture consumer trends, competitive intelligence, and regulatory shifts across regions.</li><li>Translate insights into global portfolio strategies and innovation pipelines</li></ul> Innovation &amp; Product Development <ul><li>Drive global innovation programs, ensuring new products meet consumer demand and comply with international regulations.</li><li>Be the one stop shop for innovation – where commercial team and customers channel their initial ideas and requests before being formalized into innovation projects</li></ul>&nbsp;Cross-Regional Leadership <ul><li>Align regional commercial directors and managers under a global framework.</li><li>Facilitate knowledge sharing and best practices across markets to accelerate growth.</li><li>Act as the key liaison between commercial, operations and innovations teams</li></ul>&nbsp;Regulatory &amp; Compliance Oversight <ul><li>Monitor and interpret global regulatory developments impacting tobacco categories.</li><li>Ensure portfolio decisions adhere to international laws, trade agreements, and corporate responsibility standards.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s degree in engineering ,Business, Marketing, Economics, or related field; MBA strongly preferred.</li><li>12+ years of experience in FMCG, tobacco, or regulated industries, with at least 5 years in global portfolio/category leadership.</li><li>Deep understanding of international tobacco industry dynamics, consumer behavior, and regulatory frameworks.</li><li>Proven track record in global strategic planning, innovation, and cross-market leadership.</li><li>Exceptional communication, negotiation, and stakeholder management skills across diverse cultures.</li></ul>&nbsp;Competencies <ul><li>Strategic global mindset with commercial acumen.</li><li>Ability to balance global consistency with local market needs.</li><li>Leadership and team development across geographies.</li><li>Strong influencing skills in complex stakeholder environments.</li><li>Ethical decision-making and commitment to responsible global business practices.</li></ul>

Role Description: <ul><li>The Warehouse Technician will be responsible for executing material handling, inventory management, and warehouse operations in support of a sterile pharmaceutical manufacturing facility producing injectable IV bag products, including high potent APIs and controlled substances.</li><li>This role will ensure materials are received, stored, issued, and shipped in compliance with cGMP, DEA, and site safety requirements.</li><li>The Warehouse Technician will play a key role in maintaining accurate inventory records, supporting production schedules, and ensuring the cleanliness, organization, and security of the warehouse.</li></ul> Responsibilities: <ul><li>Receive, inspect, and verify incoming materials, components, and supplies against purchase orders and specifications.</li><li>Ensure proper storage of raw materials, packaging components, and controlled substances in compliance with cGMP, DEA, and safety requirements.</li><li>Accurately issue and deliver materials to production areas based on production schedules and work orders.</li><li>Operate warehouse equipment such as forklifts, pallet jacks, and material handling devices in a safe and compliant manner.</li><li>Perform cycle counts, physical inventory counts, and reconciliation of discrepancies in coordination with Inventory Control.</li><li>Maintain warehouse cleanliness, organization, and environmental conditions per site procedures and regulatory requirements.</li><li>Document all material transactions in the inventory management system, ensuring data accuracy and adherence to data integrity principles.</li><li>Prepare shipments of materials, components, or finished products in compliance with applicable regulations, including hazardous material handling requirements.</li><li>Support material sampling activities, including coordination with Quality Control for testing.</li><li>Assist in warehouse procedure creation, updates, and continuous improvement initiatives.</li><li>Ensure DEA security and access control measures are followed for controlled substances.</li><li>Collaborate with Production, Quality, Planning, and Procurement to ensure timely material availability for manufacturing operations.</li></ul> Requirements: Qualifications/Experience: <ul><li>High school diploma or equivalent required; Associate’s degree preferred.</li><li>Minimum of 2 years of warehouse or material handling experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience handling controlled substances and/or high potent APIs preferred.</li><li>Knowledge of cGMP, DEA, and OSHA requirements for material handling and storage.</li><li>Experience operating forklifts and other warehouse equipment; forklift certification preferred.</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and accuracy in documentation and inventory management.</li><li>Familiarity with inventory management systems and ERP software.</li><li>Ability to work effectively in a fast-paced, highly regulated environment.</li><li>Strong organizational skills with the ability to prioritize tasks.</li><li>Good communication and teamwork skills.</li><li>Commitment to safety, compliance, and maintaining a secure warehouse environment.</li><li>Ability to lift and move materials in accordance with safety guidelines.</li></ul>

Responsibilities: <ul><li>Supervise daily financial data entry in the ERP system, ensuring accuracy and completeness, and prepare and post journal entries along with general ledger account reconciliations.</li><li>Supervise monthly, quarterly, and annual closings, making necessary adjustments to capture all financial activities and facilitate the Record to Report process by supplying detailed financial data for management review.</li><li>Lead and mentor a team of general accounting &amp; reporting analysts with 5-20 direct and indirect reports, fostering a collaborative and efficient work environment.</li><li>Analyze balance sheet and income statement accounts, providing insightful reports and conducting financial variance analysis to deliver actionable insights for informed decision-making.</li><li>Review financial reports that ensure compliance with accounting standards and local regulations while collaborating with various departments to integrate financial data and streamline processes.</li><li>Act as the primary contact for statutory reporting, working closely with external auditors and consultants to ensure compliance and accuracy, and assist in audit preparations by providing necessary data and reports.</li><li>Collaborate with cross-functional teams to optimize general accounting &amp; reporting process</li><li>Ensure compliance with relevant internal policy, accounting standards and regulations related to general accounting.</li></ul> Requirements: <ul><li>Bachelor’s degree in Accountancy</li><li>7 + years of experience in general accounting and financial reporting</li><li>2 + years in a management role</li><li>Strong analytical skills with the ability to interpret financial data and generate reports.</li><li>Excellent attention to detail and ability to work under tight deadlines</li><li>Strong leadership and people management skills</li><li>CPA designation</li></ul>

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46 regulations Jobs found

Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

EHS Manager

Facilities Technician

Sales Manager - Emergency Lighting and Fire Alarm & Detection Systems

Senior Manager - Portfolio Development

Warehouse Technician

General Accounting Lead

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Skills

Industry

Location

Jobtitle

46 regulations Jobs found

Site Quality Leader

EHS Analyst

Manager, Production & CI

DEA Manager

EHS Manager

Facilities Technician

Sales Manager - Emergency Lighting and Fire Alarm & Detection Systems

Senior Manager - Portfolio Development

Warehouse Technician

General Accounting Lead

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

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TALENT

COMPANY

Contact Us

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