Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

Quality Manager

Logistics Analyst

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

Project Manufacturing Leader

Manager II – Manufacturing & Process Development Engineering

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>Manage full-cycle recruitment (sourcing to onboarding).</li><li>Collaborate with hiring managers to understand hiring needs.</li><li>Source candidates through job portals, social media, and referrals</li><li>Screen, interview, and assess candidates.</li><li>Coordinate interviews and manage stakeholder communication.</li><li>Maintain recruitment data and track hiring metrics.</li><li>Ensure a strong candidate experience and employer branding.</li></ul> Requirements: <ul><li>5+ years of experience in talent acquisition/recruitment.</li><li>Strong sourcing and interviewing skills.</li><li>Familiarity with ATS and recruitment tools.</li><li>Excellent communication and stakeholder management abilities.</li><li>Ability to work in a fast-paced environment.</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>

Responsibilities: <ul><li>Maintain &amp; report KPIs related to Freight, Duty, Warehousing, and Inventory to drive stakeholder engagement &amp; action.</li><li>Act as a liaison between regional supply chain leaders, Global Logistics, and Finance to collect known headwinds, tailwinds, and cost reduction projects for inclusion in the quarterly consensus forecast</li><li>Track attainment to forecast every month, including Pareto analysis of any misses &amp; gap closure plan</li><li>Challenge existing targets &amp; identify opportunities for further improvements by partnering with the Global Logistics &amp; Global Trade Services organizations</li><li>Drive adherence &amp; standardization in the Premium Freight approval workflow, including training, specific guidelines for customer liability, and data input and reconciliation at the regional level</li><li>Identify and lead a project(s) that directly contributes to freight and/or duty cost reduction</li><li>Develop guidelines for inventory stocking strategy (Make-To-Stock / Make-To-Order), Safety Stock, Lot Sizes</li><li>Collaborate with the Master Data team to review and maintain system parameters in accordance with the latter.</li><li>Lead Slow-Moving / Obsolete inventory cadence &amp; drive actions to completion, including End-of-Life procedure</li><li>Integrate with Corporate initiatives for inventory optimization (ABC/FMR, Healthy Stock methodology)</li><li>Create innovation and digitize reports for better data presentation and action determination.</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Information Systems, or a related field. A Masters degree is preferred.</li><li>Proven experience 5+ years in master data management, data governance, or a related field, preferably in a supply chain planning environment.</li><li>Strong knowledge of supply chain planning processes, including demand planning, inventory management, and production planning.</li><li>Proficiency in utilizing master data management tools and systems (e.g., SAP MDG, Informatica MDM, etc.).</li><li>Solid understanding of data governance principles, data quality management, and data lifecycle management.</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain web applications using Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Implement and manage APIs and microservices architecture</li><li>Ensure the performance, quality, and responsiveness of applications</li><li>Identify and correct bottlenecks and fix bugs</li><li>Partner with business stakeholders and operations team to identify and manage KPIs</li><li>Evaluate the performance of processes, services, and outcomes and drive performance improvement</li><li>Independently solve complex issues, lead a team of junior and mid-level developers</li><li>Other duties as assigned</li></ul> Requirements: <ul><li>Bachelor’s degree in computer science, Information Technology, or related field. Minimum of 12-15 years offull stack development related work experience</li><li>Strong oral and written communication skills</li><li>Expert in Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Strong analytical skills with the ability to collect, organize, and analyze data</li><li>Attention to detail and accuracy is critical</li><li>Working knowledge of cloud platforms (e.g., AWS, Azure)</li><li>Adept at presenting findings in MS PowerPoint and MS Word</li></ul>

Role Description:&nbsp; <ul><li>We are hiring a Supply Chain Project Engineer to lead and manage engineering and CAPEX projects within a manufacturing environment.&nbsp;</li><li>This role involves working closely with global engineering teams and plant operations to deliver projects on time, within budget, and aligned with business goals.</li></ul> Responsibilities: <ul><li>Lead end-to-end project execution (design, installation &amp; commissioning).</li><li>Support technical proposals, cost estimation, and project planning.</li><li>Coordinate with suppliers, contractors, and cross-functional teams.</li><li>Supervise installation and construction activities on-site.</li><li>Ensure projects meet EHS, quality, and food safety standards.</li><li>Manage budget, timelines, and resource planning.</li><li>Work closely with global engineering, production, maintenance, and operations teams.</li><li>Support CAPEX planning and execution for plant initiatives.</li></ul> Requirements: <ul><li>Bachelor’s degree in engineering as Mechanical, Electrical or equivalent. MBA or Management degree is preferred.</li><li>Working with manufacturing environment is preferred. Minimum 4 years of engineering experience with minimum 3 years for project management.</li><li>Knowledge of mechanical, electrical and construction/structure are required. Also, good computer background is a must.</li><li>English communication skill is necessary in both speaking and writing.</li><li>Able to work with government officers and public organizations.</li><li>Knowledge of food industry and financial issues including CAPEX&nbsp;</li></ul>

Responsibilities: Product Costing <ul><li>Calculate and maintain standard costs for products.</li><li>Determine labor rates and overhead absorption rates.</li><li>Maintain costing sheets and databases, including new product costing and pricing support.</li><li>Perform quarterly standard cost updates (cost roll).</li></ul> Cost Analysis <ul><li>Analyze and explain variances including:</li><li>Purchase price.</li><li>Material usage.</li><li>Labor and machine rates.</li><li>Efficiency and overhead.</li><li>Compare actual costs to standard costs and investigate deviations.</li><li>Identify root causes of cost fluctuations.</li><li>Analyze cost trends and evaluate cost behavior (fixed vs. variable).</li></ul> Month-End Activities <ul><li>Support month-end close with cost accounting entries.</li><li>Prepare journal entries with appropriate documentation.</li><li>Ensure accurate Cost of Goods Sold (COGS) reporting in P&amp;L.</li><li>Reconcile general ledger accounts with subledgers.</li></ul> Budgeting &amp; Forecasting Support <ul><li>Support preparation of cost budgets for operations/production.</li><li>Provide historical cost data for planning and analysis.</li><li>Calculate standard costs for budget models.</li><li>Monitor actual performance vs. budget.</li><li>Support forecasting through cost projections.</li></ul> Cost Optimization &amp; Business Partnering <ul><li>Identify cost reduction opportunities through data analysis.</li><li>Track and validate savings from cost improvement initiatives.</li><li>Partner with procurement on material cost updates.</li><li>Work closely with production on labor and overhead rates.</li><li>Provide cost insights to support operational decision-making.</li></ul> Requirements: <ul><li>Education &amp; Experience.</li><li>Bachelor’s degree in Finance, Accounting, Economics, or related field.</li><li>Professional accounting qualification is a plus.</li><li>Minimum 3+ years of experience in cost accounting (manufacturing environment preferred).</li><li>Experience in product costing and standard costing methodologies.</li><li>Exposure to SAP or similar ERP systems.</li></ul> Technical Skills <ul><li>Strong understanding of cost accounting principles and practices.</li><li>Advanced proficiency in Microsoft Excel.</li><li>Knowledge of Power BI and/or VBA is an advantage.</li><li>Familiarity with integrated systems and costing modules.</li></ul> Functional &amp; Industry Experience <ul><li>Experience working in a manufacturing or production environment.</li><li>Understanding of production processes, cost drivers, and operational workflows.</li><li>Hands-on exposure to plant-level costing and operational finance.</li></ul> Core Competencies <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy.</li><li>Structured and organized approach with the ability to manage multiple priorities.</li><li>Ability to work cross-functionally and collaborate with operations and supply chain teams.</li><li>Strong communication skills in English (written and verbal).</li></ul>

Role Description: <ul><li>The Project Manufacturing Leader is a Project Core Team Member, in charge of the industrialization of all client production lines involved in a project Value Stream, across several client plant locations when applicable.</li><li>The PML is responsible for achieving key targets in terms of Industrial Timing, Capacity, Quality and Production Costs in line with the Planisware Work packages and deliverables on time completion (or Project LeanPD milestones) requirements. His/Her role is to define and implement the best Production System and line Concepts while ensuring that all client Global Auto industrial strategy and standards are followed.</li><li>PML involvement with a new project starts at RFQ, between G0 and G1 and lasts until SOP + 3 months.</li><li>The PML reports directly to the regional ME organization, to the PML Manager/Director and functionally to the Project Manager.</li></ul> Responsibilities : Design for Manufacturing : <ul><li>The PML participates in the Product Design activities led by the Product Design Engineering Team, contributing towards reaching a product design compliant with client Industrial Targets and allowing maximum Production Profitability.</li><li>He/She leads Technology and comparative studies in case of multiple options and ensures that Process Feasibility is optimal and validated by experts.</li></ul> Footprint and Make or Buy Studies: <ul><li>With the support of his management and considering inputs from the project team, the PML conducts a preliminary footprint analysis, including Make or Buy comparative Studies.</li><li>The PML submits the proposal to the Regional/Global Industrial Strategy team for final decision.</li></ul> Production System Definition: <ul><li>(Plant: Production System, Physical lay-out) In the early program Development phase, the PML organizes, leads and follows-up the Lean Industrial Design workshop activity, involving all Project and Plant Team functions, under coordination of the ME or Launch Director.</li><li>Based on the initial industrial assumptions, he/she builds the initial Plant internal Material &amp; Information Flow Diagram (MIFD)/VSM, Line lay-out, Plant lay-out with Production System and Logistics areas footprint calculations.</li><li>Before Program CER/Capex Committee Meeting, he/she leads the Tool and machine Design Workshop, out of which plant delivers the detailed</li><li>Production Line layout and Advanced VSM. Confirm the proposed Production System including traceability and conformity.</li><li>PML leads the assessment of any equipment refurbishment needs for the project relying on the appropriate internal or external experts and validate the effective equipment refurbishment timing and cost with vendors.</li><li>Job Description The PML identifies any Industrial risk, defines a back-up plan for critical processes and provides Industrial Impact on any Engineering Change Request.</li></ul> Process FMEA: <ul><li>PML participates in the definition of Key Product Characteristics (KPC) and Key Control Characteristics (KCC) He/She coordinates and leads the PFMEA methodology during program phase with active participation of Process Experts, including PLTL or Process Engineer.</li><li>Once the initial PFMEA is completed, ensure that actions are implemented with all updates included prior to handover to the Plant at Mass Production Trial (MPT).</li></ul> CER Committee: <ul><li>(Product Manager initially presenting because of Commercial discussion then Project discussion) PML ensures Capacity analyses are completed prior to adding new equipment to the project.</li><li>He/She optimizes Project Investment through Reuse, Bundling, Massification etc. He/She builds and monitors the detailed Project Investment List.</li><li>He/She prepares and leads the Project CER/Capex industrial Presentation, submitting CER request and approval follow-up after Project and Plant Managers have validated the investments.</li><li>Once CER is presented, he/she ensures timely CER submission/validation and follow-up in line with the industrial timing.</li></ul> Industrial Timing: <ul><li>PML builds, updates &amp; monitors the complete Project Industrial timing plan for tools, equipment, Packaging, traceability and associated processes to meet all internal (MPT) and external Customer milestones on time and right first time, from specification to final acceptance.</li><li>He coordinates Project Product Engineers and Supply Chain Engineers within the Project Team and track Plants readiness status in collaboration with the Plant PLTL.</li><li>The PML coordinates Traceability Implementation, Machine and tooling acceptance, tracking improvement actions with a robust PDCA where needed. Responsible to organize Tooling &amp; Equipment progress status reviews involving the plant PLTL.</li></ul> Industrial Performance <ul><li>PML defines and tracks main Industrial Performance indicators: - MMR and Work Content - Scrap Process rate - Process Capabilities - Capacity Status and Process Cycle Time, including Equipment Utilization Monitoring (data from plant) - Rework monitoring - Material Yield - Launch Costs consolidated in the Business Plan - Project Investment PML ensures that the most suited technical solutions for Project Financial KPI improvement are investigated through standard, automation, digitalization with payback analysis.</li></ul> PAC reviews: <ul><li>Reporting PML reports progress status on Manufacturing Work Packages and related program milestones. All PMLs participate in the PML -or regional ME Department weekly routine.</li></ul> Requirements: <ul><li>Masters degree in engineering, or equivalent professional experience.</li><li>Minimum 5 years of proven experience in production or industrial area preferably in automotive sector.</li><li>Strong ability to work in an international and multicultural environment with complex matrix organization. Team building and positive mindset.</li><li>Leadership with ability to interact and coordinate complex subjects with technical teams. Proactive with a vision of long-term impact and problem anticipation.</li><li>Knowledge in project management process, Quality Control tools in production, Lean Line Design.</li><li>Result oriented with strong written, verbal communication skills. Fluent English required.&nbsp;</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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282 solid work Jobs found

Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

Quality Manager

Logistics Analyst

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

Project Manufacturing Leader

Manager II – Manufacturing & Process Development Engineering

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Skills

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282 solid work Jobs found

Associate Director RA & QA

DEA Manager

Talent Acquisition Specialist

Quality Manager

Logistics Analyst

Sr. Application Developer

Assistant Manager, SC Projects

Cost Accountant

Project Manufacturing Leader

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