HR Regional Partner III

Site Quality Leader

HR PARTNER II

Data & ML Architect

Manager, Production & CI

Associate Director RA & QA

DEA Manager

Quality Manager

Manager – Operations

Manager II – Manufacturing & Process Development Engineering

Responsibilities:&nbsp;Business Partnership &amp; Leadership <ul><li>Act as the primary HR business partner to the Plant Manager and site leadership team.</li><li>Support Site Complexity Assessment and implementation of the operating model, ensuring workforce structure, leadership layers, and HR practices align to site complexity.</li><li>Participate as a full member of the plant leadership team, with regular site presence and engagement in the manufacturing environment.</li><li>Translate BU and site strategy into clear workforce, talent, and culture priorities.</li></ul> Workforce &amp; Talent Strategy <ul><li>Develop and execute a site‑specific workforce plan aligned to AD&amp;M business cycles, growth plans, and skill requirements.</li><li>Embed career paths and competency frameworks into talent planning, development, and succession discussions.</li><li>Partner with regional HR and COEs on talent planning, succession, performance management, and compensation cycles.</li><li>Coach leaders on performance, engagement, retention, and leadership effectiveness.</li></ul> Employee Relations &amp; Culture <ul><li>Experience interpreting and operating within the constraints of a Collective Bargaining Agreement.</li><li>Lead positive employee relations through proactive coaching, issue resolution, and culture reinforcement.</li><li>Drive action planning from Every Voice Counts engagement results and hold leaders accountable for outcomes.</li><li>Serve as a visible champion of safety, inclusion, accountability.</li></ul> Operational Excellence &amp; Change <ul><li>Lead and support change management tied to organizational alignment, business growth, and operational transformation.</li><li>Identify HR process improvement opportunities and partner with the regional team to drive standardization and scalability using (lean operating model).</li><li>Ensure disciplined execution of HR programs, policies, and compliance requirements.</li></ul> Regional &amp; Enterprise Integration <ul><li>Operate within the HR Regional Partner model, aligning local actions to regional standards.</li><li>Leverage HR Service Centers and COEs for delivery while maintaining local ownership and accountability.</li><li>Collaborate across sites and BUs to share best practices and improve HR capability at scale.</li></ul> Requirements:&nbsp; What a Strong Candidate Looks Like Experience &amp; Capability <ul><li>Bachelor’s degree required, HR or related field preferred.</li><li>7+ years of progressive HR experience, with demonstrated success as an HRBP or HR Generalist in a manufacturing or operational environment within a unionized environment</li><li>Proven ability to influence and partner with leaders in a matrixed organization.</li><li>Strong balance of strategic thinking and hands‑on execution.</li><li>Must have experience working within a Union environment.</li></ul> Leadership &amp; Style <ul><li>Credible coach and advisor who earns trust through presence, judgment, and follow‑through.</li><li>&nbsp;Experience collaborating with union representatives, often requiring strong negotiation and conflict resolution.</li><li>Comfortably operating in ambiguity while driving structure, discipline, and results.</li><li>Data‑informed, process‑oriented, and biased toward action.</li><li>High emotional intelligence with the ability to challenge leaders constructively.</li></ul> Operating Expectations <ul><li>On‑site role with regular plant‑floor engagement.</li><li>Travel within regions up to ~10%.</li><li>Commitment to safety, compliance, and ethical leadership.</li></ul>

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: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: Strategic Leadership: <ul><li>Set the vision and direction for data and AI architecture for project and client.</li><li>Influence enterprise data and AI strategies, driving adoption of best practices in data, ML, and AI architecture.</li><li>Mentor and develop junior architects and engineers, fostering a culture of technical excellence and innovation.</li></ul> Architectural Excellence: <ul><li>Architect and design enterprise-scale data platforms and ML/AI solutions for scalability, reliability, and performance.</li><li>Define and enforce data and ML architecture standards, patterns, and governance frameworks for data pipelines, ML workflows, and analytics platforms.</li><li>Lead solution design for integrating data from diverse sources (streaming, batch, cloud, on-premises) using Azure, AWS, and GCP services.</li></ul> AI &amp; ML Leadership: <ul><li>Architect advanced Data Science, ML and AI solutions, including NLP, RAG LLM and Agentic AI systems.</li><li>Oversee the implementation of MLOps frameworks, ensuring robust deployment, monitoring, and lifecycle management of ML models.</li><li>Evaluate and recommend emerging AI/ML technologies and platforms, driving innovation in intelligent data products.</li><li>Provide Ethical AI leadership to ensure intelligent solutions are implemented when required and in safe methods.</li></ul> Technical Leadership: <ul><li>Oversee data modelling (e.g. medallion architecture), data governance, and quality frameworks. Implementing technical reviews and driving high standards.</li><li>Collaborate with engineering and DevOps teams to establish CI/CD and MLOps architectures using Azure DevOps, Kubernetes, and Terraform.</li><li>Guide the selection and implementation of visualization and analytics tools (Power BI, Tableau, PowerApps).</li></ul> Stakeholder Engagement: <ul><li>Engage with senior stakeholders to translate complex business requirements into technical solutions and strategic roadmaps.</li><li>Ensure all solutions meet security, compliance, and performance standards, and align with enterprise architecture principles.</li></ul> Innovation &amp; Emerging Technologies: <ul><li>Apply modern data and AI architecture patterns (Cloud Native, Steaming/batch ingestion, Agentic AI Design) and leverage platforms such as AI/ML, Big Data, and Data Lakehouse.</li></ul> Requirements: <ul><li>Minimum 8 years’ experience client facing roles specializing in Data and Architecture roles.</li><li>Experience in both Agile and Waterfall project environments.</li><li>Strong stakeholder management and communication skills.</li><li>Security and compliance awareness.</li><li>Industry certifications (e.g., AWS Solution Architect, Azure Data Engineer, GCP Data Engineer).</li><li>Experience mentoring or managing technical teams.</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 Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</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: <ul><li>Drive quality performance during rapid production ramp-up</li><li>Lead containment actions and 8D corrective action activities</li><li>Build and maintain strong quality gates and inspection processes</li><li>Improve yield, reduce defects, and enhance customer satisfaction</li><li>Partner with Operations, Engineering, Program, Supply Chain, and Production teams</li><li>Promote early escalation, data-driven problem solving, and continuous improvement</li><li>Monitor quality metrics and drive corrective/preventive actions</li><li>Support manufacturing readiness and process compliance</li></ul> Lead the site Quality organization covering: <ul><li>Product Quality</li><li>Signal Integrity Quality</li><li>Incoming Quality</li><li>Quality Engineering</li><li>Quality Management System</li><li>Customer quality and corrective action</li><li>Work closely with regional quality leaders, regional manufacturing counterparts, and key stakeholders</li></ul> Requirements: <ul><li>Manufacturing quality leadership experience</li><li>Electronics, cable assembly, connector, EMS, automotive electronics, or high-precision manufacturing background</li><li>Knowledge of 8D, FMEA, Control Plan, SPC, MSA, CAPA, Pareto, and audit management</li><li>Exposure to signal integrity, high-speed interconnect, RF, test engineering, or data center hardware will be an added advantage</li><li>Experience working in a multinational and fast-paced ramp environment</li></ul>

Role Description: <ul><li>The above position has been created to lead a team of Mechanical Designers, Electrical Automation Engineers in the Operations team to define the process and build them with Maintenance and Facility responsibility of the Plant</li></ul> Responsibilities: <ul><li>Responsible for achieving the Safety, Quality, Cost and Delivery parameters of all the Value Streams with the help of respective Value Stream Leader.</li><li>Responsible to achieve the TPM(Total Productive Maintenance) KPI of Maintenance sections (Machines and Testers).</li><li>Ensure implementation and effective usage of all the relevant Lean Tools (Our client Tools) in the Value Streams and Maintenance.&nbsp;</li><li>Ensure the accuracy of the WIP Stock with continued reduction as per Lean principles.</li><li>YOY Productivity improvement for the Operations through Cost Saving Projects, Efficiency improvement, Operational Material Savings.</li><li>Should be able to scale up the teams competencies to meet the requirements of the new product and processes.</li><li>Should be able to demonstrate Mental and Change agility to deal with technology shift as required for New product introduction.</li></ul> Requirements:&nbsp; <ul><li>B.E, Diploma (Mechanical, Production) </li><li>Master’s in business administration would be an added advantage&nbsp;</li><li>12-15 years total experience, with hands on experience in the Manufacturing department of a Mass production unit (Automotive, EMS</li><li>At least 4-5 years experience of leading the operations function in Molding/Headers/Connectors manufacturing.</li></ul>

Responsibilities: Lead a team of engineers who will: <ul><li>Develop power connector assembly manufacturing process in accordance with LEANPD product development.</li><li>Drive for excellence in existing manufacturing technologies and methods.</li><li>Strive to implement new manufacturing technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for manufacturability; realizes sample tooling, product samples, and prototypes.</li><li>Design, develop, and qualify tooling and processes to meet company DDN quality and production standards.</li><li>Support the supply chain to verify supplier compliance and capability.</li><li>Act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with the project management team to understand current and future strategic business needs</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need</li><li>Provide readouts to Senior manager and Director-level cross-functional management as necessary</li><li>Work with the Philippines operations team to assign resources necessary for the successful execution of new product development</li><li>Facilitate and coordinate cross-functional communication across globally matrixed organizations</li></ul> Requirements: <ul><li>Bachelors or above degree with mechanical/electrical related majors.</li><li>At least 5 years of managerial-level experience related to a multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in the connector assembly industry is preferred.</li><li>Fluent in English and good presentation skills.</li><li>Familiar with MS software.</li><li>Familiar with industrial specification (i.e., IPC 620).</li><li>Familiar with Stamping / Plating / Molding / Assembly processes</li></ul>

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128 leadership Jobs found

HR Regional Partner III

Site Quality Leader

HR PARTNER II

Data & ML Architect

Manager, Production & CI

Associate Director RA & QA

DEA Manager

Quality Manager

Manager – Operations

Manager II – Manufacturing & Process Development Engineering

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Skills

Industry

Location

Jobtitle

128 leadership Jobs found

HR Regional Partner III

Site Quality Leader

HR PARTNER II

Data & ML Architect

Manager, Production & CI

Associate Director RA & QA

DEA Manager

Quality Manager

Manager – Operations

Manager II – Manufacturing & Process Development Engineering

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

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TALENT

COMPANY

Contact Us

JOBS BY SKILLS

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