HR Regional Partner III

Site Quality Leader

QC Officer

Data & ML Architect

EHS Analyst

AVP, Digital Analytics

Head of Sales

Project Manager

Manager, Production & CI

Associate Director RA & QA

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>

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</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: 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: <ul><li>Lead and deliver Digital Measurement Analytics for Digital Platforms in Agile methodology to drive digital data strategy that includes collection &amp; validation of data and reporting.</li><li>Partner with onsite Stakeholders and various process owners in marketing, technology and digital teams to plan and implement strategic priorities.</li><li>Present analytical results and actionable recommendations to key stakeholders on a recurring cadence, and propose innovative analytics solutions to drive business growth and enhance the customer experience.</li><li>Responsible for team’s effective communication, project deliverables, coaching team on adhering to expected timelines, accuracy &amp; compliance with meticulous project management.</li><li>Lead internal initiatives, perform other duties and/or special projects, as assigned.</li></ul> Requirements: <ul><li>Degree in Statistics, Mathematics, Economics, Engineering, or any other quantitative streams with 4+ years of hands-on relevant Analytics experience.</li><li>Minimum 6+ years of relevant work experience in lieu of specified degree.</li><li>2+ years of experience in Digital or Web Analytics Domain utilizing tools such as Adobe or Google Analytics and 2+ years of experience in SAS or SQL.</li><li>1+ years of Experience in Managing People, Coordinating work, Supervising, Evaluating performance and ensuring employees are trained.</li><li>Minimum 1+ years of experience in Data visualizations tools such as Tableau to drive insights.</li><li>Excellent oral and written communication skills with ability to collaborate, articulate and present solutions cutting across functional/agile teams in a simple yet compelling manner</li></ul>

Responsibilities: <ul><li>Achievement of the direct project sales targets for the Thailand business&nbsp;</li><li>To lead and implement the yearly strategic sales business plan&nbsp;</li><li>Support existing and develop new distributors/business partners to promote and sell UPS and associated critical power systems&nbsp;</li><li>Drive weekly and monthly sales meetings ensuring all sales opportunity data accuracy&nbsp;</li><li>Develop and grow strong business relationships with electrical contracting firms including, education and training, specification influence for design and construct projects, preparation of quotes for tenders and requests&nbsp;</li><li>Responsible for the development and growth of specific end user accounts</li></ul> Requirements: <ul><li>Degree/Diploma in Engineering and/or equivalent&nbsp;</li><li>Experience in leading a team&nbsp;&nbsp;</li><li>Minimum 10 years of sales and business development experience in the power management, industrial automation or related industry</li><li>Experience in selling Uninterrupted Power supplies (UPS)</li></ul>

Responsibilities: <ul><li>Manage and supervise team’s projects’ progress</li><li>Project management– meeting project milestones, cost control/savings for projects and timely project billing.&nbsp;&nbsp;</li><li>Validate suppliers’ quotations are in accordance to site requirements</li><li>Ensure sales team provide the required info to project team for efficient project execution</li><li>Support sales team during bidding phase on project structure presentation and site surveys</li><li>Be clear on project payment milestones and carry out billing timely</li><li>Monthly billing forecasting to reporting manager</li><li>Ensure proper handover to service department with full documentation</li><li>Ensure proper handover documents are submitted to clients for their signatories</li></ul> Requirements: <ul><li>Diploma or Degree in engineering</li><li>10+ years or more in project management responsibilities in low voltage systems</li><li>Experience in managing data centers projects</li><li>Experience in dealing with Contractors, Facilities managers, end users, consultants and managers</li><li>Experience in managing 3rd party subcontractors&nbsp;</li><li>Ability to communicate English with regional counterparts</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>

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220 data regulations Jobs found

HR Regional Partner III

Site Quality Leader

QC Officer

Data & ML Architect

EHS Analyst

AVP, Digital Analytics

Head of Sales

Project Manager

Manager, Production & CI

Associate Director RA & QA

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220 data regulations Jobs found

HR Regional Partner III

Site Quality Leader

QC Officer

Data & ML Architect

EHS Analyst

AVP, Digital Analytics

Head of Sales

Project Manager

Manager, Production & CI

Associate Director RA & QA

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

EMPLOYER

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COMPANY

Contact Us

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