Procurement Specialist

Process Engineering Manager

Site Quality Leader

Registered Operations Leader

HR PARTNER II

Data & ML Architect

TA Supervisor

Manager, Production & CI

Associate Director RA & QA

DEA Manager

Role Description: <ul><li>The Procurement Specialist is responsible for managing the procurement of direct and indirect materials and services to ensure uninterrupted supply to manufacturing operations while achieving cost, quality, delivery, and working capital objectives. </li><li>The role partners closely with Production Planning, Operations, Quality, Finance, and Global Procurement to execute sourcing strategies, manage supplier performance, and support continuous improvement initiatives across the supply chain.&nbsp;</li><li>The successful candidate will have strong procurement execution skills, supplier management experience, and a proactive approach to resolving supply risks and driving operational excellence.&nbsp;</li></ul> Responsibilities: Procurement &amp; Supply Management&nbsp; <ul><li>Execute procurement activities for assigned direct materials, packaging materials, indirect spend categories, and services.</li><li>Convert purchase requisitions into purchase orders and manage end-to-end procurement transactions within SAP.</li><li>Ensure material availability to support production plans and customer commitments.</li><li>Monitor supplier delivery performance and proactively manage supply risks.</li><li>Coordinate with planning and operations teams to address shortages, delays, and capacity constraints.</li><li>Maintain optimal inventory levels in line with working capital and service objectives.&nbsp;</li></ul> Supplier Management&nbsp; <ul><li>Manage day-to-day supplier relationships and performance.</li><li>Monitor supplier KPIs including:&nbsp;&nbsp;On-Time Delivery (OTD), Quality performance, Lead time adherence, Responsiveness&nbsp;, Cost competitiveness</li><li>Conduct supplier performance reviews and support corrective action implementation where required.&nbsp;</li><li>Escalate supply risks and develop mitigation plans to ensure business continuity.</li></ul> Cost &amp; Contract Management <ul><li>Support sourcing initiatives and cost reduction projects.</li><li>Obtain quotations and conduct commercial evaluations.</li><li>Participate in supplier negotiations under guidance from Global Procurement or Supply Chain leadership.</li><li>Support implementation of payment term optimization initiatives.</li><li>Ensure contract pricing and procurement terms are accurately maintained within systems.&nbsp;&nbsp;</li></ul> Inventory &amp; Working Capital Management&nbsp; <ul><li>Collaborate with planning teams to optimize inventory levels.</li><li>Identify excess, obsolete, and slow-moving inventory risks.</li><li>Support inventory reduction initiatives without compromising customer service.</li><li>Monitor supplier lead times and MOQ impacts on inventory performance.</li></ul> SAP &amp; Process Excellence&nbsp; <ul><li>Maintain accurate procurement master data including:&nbsp;&nbsp;Vendor records, Pricing information, Lead times, Procurement parameters&nbsp;</li><li>Support SAP implementation and continuous process standardization initiatives.</li><li>Ensure compliance with procurement policies, approval authorities, and audit requirements.</li><li>Drive continuous improvement opportunities in procurement processes and supplier collaboration.</li></ul> Requirements:&nbsp; <ul><li>Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline.</li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred.</li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.</li><li>Experience in procurement or supply chain within a manufacturing environment.</li><li>Good understanding of supplier management, inventory control, and material planning (MRP).</li><li>Proficiency in SAP and Microsoft Excel for procurement and data analysis.</li><li>Strong communication, negotiation, and problem-solving skills.</li><li>Ability to collaborate effectively with cross-functional teams and suppliers.</li><li>Experience supporting cost-saving, process improvement, or SAP implementation initiatives.&nbsp;&nbsp;</li></ul>&nbsp;&nbsp;

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</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:&nbsp; <ul><li>Manage activities that support business results, revenue growth, client experience and efficiencies in practice.</li><li>Manage resources to achieve business results, including revenue and client acquisition targets.</li><li>Partner with Branch Manager to ensure advisor business plans are completed and marketing events are tracked and measured.</li><li>Assist advisors in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, crafting an agenda and summary of meeting, escorting clients to advisors office and providing follow-up. Prepare and ensure new business paperwork processes are successfully filled out.</li><li>Provide general administrative duties such as answering phones, processing reports, preparing correspondence, setup files, etc.</li><li>Build, manage, track and analyze reports and branch vitals.</li><li>Review advisor expense reports, branch P &amp; L, budgeting, reporting/correcting errors, identify and implement expense reduction opportunities.</li><li>Partner with Registered Principal to ensure compliance support is established and training needs are met.</li><li>Lead real estate and facilities initiatives.</li><li>Lead, coach, mentor and provide performance management for direct reports.</li><li>Partner with Senior Operations Leader and Regional Director of Operations to determine staffing needs; request, hire and allocate staff.</li><li>Conduct 1:1s with staff.</li></ul>﻿Requirements: <ul><li>Bachelors degree or equivalent.</li><li>5 - 7 years relevant experience required.</li><li>Previous successful supervisory experience including knowledge of HR policies and labor laws.</li><li>Excellent written and verbal communication skills; demonstrated ability to motivate team members to delivery results.</li><li>Ability to manage multiple priorities in a fast-paced environment with little or no supervision and strong organizational/time management skills.</li><li>Able to communicate with all levels within the organization.</li><li>Detail orientated, strong math, and analytical skills. Good organization and time management skills.</li><li>Process oriented and can work with a team. Proficient with standard business software applications.</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: Execute Hiring Strategies; <ul><li>Collaborate with Regional TA Manager, Business Leaders, HR partners, and Business teams to understand short- and long-term hiring needs.</li><li>Assist in developing and executing hiring plans, executing Global SLAs are aligned with the Business Goals</li><li>Stay informed about industry trends, market conditions, and emerging hiring practices &amp; tool</li></ul> Talent Sourcing &amp; Pipeline Development: <ul><li>Build and maintain a strong pipeline of candidates for various key roles such as NPD, NPI, PDE, MPDE and many more.</li><li>Assist the Regional TA Manager to develop and implement innovative hiring strategies using Market intelligence &amp; Talent Mapping tools.</li><li>Leverage a mix of sourcing channels: Internal/External career sites, social media Hiring such as LinkedIn, TikTok, Instagram, Facebook etc., Job Boards such as JobStreet, Monster</li><li>Familiar with hiring tools such as HireEz, ZoomInfo. Leverage employee referrals, and University hiring</li></ul> Employer Branding &amp; Candidate Engagement: <ul><li>Position the company as an employer of choice in the Engineering, Tech and manufacturing space.</li><li>Create content and campaigns targeting industry professional (e.g., webinars, blog posts, meetups, TechEvents)</li><li>Craft compelling job descriptions and recruitment materials tailored for manufacturing, Production and Engineering professionals</li></ul> Full-Cycle Recruitment: <ul><li>Deliver end-to-end recruitment: sourcing, screening, interviewing, offers &amp; compensation negotiation and onboarding</li><li>Collaborate with hiring managers to define role requirements and ideal candidate profiles.</li><li>Assist implement and monitor structured interview processes, including technical assessments</li></ul> Stakeholder Management: <ul><li>Act as the primary liaison between candidates and internal stakeholders</li><li>Provide regular hiring updates, metrics, and insights to leadership</li></ul> Data-Driven Recruiting: <ul><li>Use analytics to track sourcing effectiveness, time-to-hire, offer acceptance rates, and pipeline health.</li><li>Ensure Global Hiring Metrics, SLA and targets are aligned and achieved</li><li>Publish Daily / Weekly / Monthly / Qtrly reports on the efforts and progress</li><li>Optimize hiring funnel using recruitment metrics and KPI</li></ul> Requirements: <ul><li>Overall 8+ years of experience with Minimum of 5+ years from relevant industry</li><li>Preferably an Engineer of any discipline, but not mandatory (OR) Bachelor’s degree or higher in business administration or related field</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>

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146 leadership and supervision Jobs found

Procurement Specialist

Process Engineering Manager

Site Quality Leader

Registered Operations Leader

HR PARTNER II

Data & ML Architect

TA Supervisor

Manager, Production & CI

Associate Director RA & QA

DEA Manager

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146 leadership and supervision Jobs found

Procurement Specialist

Process Engineering Manager

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Registered Operations Leader

HR PARTNER II

Data & ML Architect

TA Supervisor

Manager, Production & CI

Associate Director RA & QA

DEA Manager

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