Project Manager

Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

Quality Manager

Customer Service Specialist

Document Controller

Manager II – Manufacturing & Process Development Engineering

VP,  Senior Audit Manager

VP, IAM Assurance Leader

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>

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: Policies and Procedures: <ul><li>Localize and implement global quality policy, procedures and systems; and review QA reports within the entire factory in order to ensure the business procedures in line with QS and global standards.</li></ul> Quality System Maintenance: <ul><li>Monitor the implementation of the quality policies, including internal audit policy; monitor effectiveness of quality system,involve the quality-related best practices activities; and coordinate quality system audit from customers and third parties</li><li>in order to ensure meet business development requirement and align with global quality policies.</li></ul> Internal Quality Audit: <ul><li>Prepare internal audit plan in order to ensure meet business development requirement and align with global quality policy.</li></ul> External Audit: <ul><li>Prepare the related information according to customer or quality agencies audit needs; coordinate the entire audit process</li><li>provide action plans to external parties base on the report findings,in order to ensure meet business development requirement and align with global quality policy.</li></ul> Document Control: <ul><li>Maintain document control system in order to meet business development requirement and align with global quality policy.</li></ul> Customer Satisfactory Survey: <ul><li>Organize and review customer satisfactory survey in order to meet business development requirement and align with global quality policy.</li></ul> Quality Metrics: <ul><li>Summary and analyze plant quality metrics, support the function department to drive the performance improvement.</li></ul> Requirements: Education, Technical Qualification &amp; Experience <ul><li>College Graduate</li><li>5-8 years quality system working experience</li><li>Manufacture plant quality system experience</li><li>Project management experience</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: Customers Management: <ul><li>Handle incoming calls and emails from assigned accounts (customers) for various sales inquiries, including information on orders, lead times, incoterms, and stock availability.</li><li>Proactively communicate with customers to ensure understanding and resolution of all order-related issues.</li></ul> Analyse Demand Forecast/ Revenue &amp; Inventory Control: <ul><li>Analyze demand forecasts for assigned accounts (customers) and review/control inventory in accordance with business unit targets.</li><li>Conduct demand planning and upload forecasts to the system, managing replenishment orders and billing for consignment customer consumption.</li><li>Generate forecast and LE reports promptly and accurately for Monthly Sales Revenue.</li><li>Review customers actual demand and forecasts to meet their requirements and conduct comprehensive analysis to avoid excess inventory or non-moving stock.</li></ul> Customer Documentation &amp; File Management: <ul><li>File all relevant sales transactions, including purchase orders, order proof lists, order acknowledgments, shipping documents, shipment reports, customer&nbsp;</li></ul> Shipment Management: <ul><li>Prepare and process shipments according to customer requests.</li><li>Collaborate with Planning/Logistics to ensure on-time delivery based on customers request dates and confirm dates for STR performance.</li><li>Oversee drop-shipment orders and ensure continuous follow-up on shipment status, particularly for critical issues.</li><li>Submit credit releases to finance for held accounts.</li><li>Coordinate with Account Managers and customers to release shipments that are on hold.</li></ul> Payment Management: <ul><li>Follow up on open disputes/invoice discrepancies with Customer, Finance &amp; Sales to ensure the best possible A/R results. If necessary, issue credit/debit notes to resolve discrepancies.</li></ul> Requirements: <ul><li>Bachelor degree in related field.</li><li>5-10 years minimum in customer service/procurement or production planning, proficient in both written and spoken English, PC literate with Microsoft Window software.</li><li>Self-initiative, perseverance, people oriented and able to travel locally and aboard for short assignment</li></ul>

Role Description : <ul><li>This role supports project teams by controlling documentation for EPC projects—identifying, uploading and distributing engineering deliverables and maintaining electronic and hardcopy repositories with accurate indexing, revision control, metadata and access permissions.</li><li>It operates EDMS (SharePoint, ProjectWise), manages the change control lifecycle (issue/revise/approve/distribute/archive) and reviews documents for completeness and contractual/QMS compliance.</li><li>The role maintains traceability, transmittals and audit trails, prepares reports, supports technical reviews and handovers, follows up on pending reviews, and safeguards data integrity and confidentiality.</li><li>Control all documentation activities: identify, upload and distribute engineering deliverables.</li></ul> Responsibilities: <ul><li>Maintain electronic and hardcopy repositories with accurate indexing, revision control and retrieval.</li><li>Operate and administer EDMS (SharePoint, ProjectWise, etc.): uploads, metadata, permissions and folder structures.</li><li>Review drawings, specifications, change orders, submittals and vendor documents for completeness, format and contractual/QMS compliance; resolve discrepancies.</li><li>Manage the change control lifecycle: issue, revise, approve, distribute, archive and retire controlled copies.</li><li>Ensure documents are correctly dated, versioned and authorized prior to release.</li><li>Maintain traceability registers, revision histories, distribution lists, transmittals and audit trails.</li><li>Prepare transmittals, distribution notices, status updates and ad?hoc project reports.</li><li>Support technical reviews, coordination meetings and project closeout / handover documentation packs.</li><li>Proactively follow up on pending actions, approvals and overdue reviews.</li><li>Develop and maintain document procedures, metadata standards and templates; identify and implement improvements.</li><li>Provide day to day support for document access, retrieval, formatting/numbering and stakeholder queries, while maintaining access controls, data integrity and compliance with internal/ISO/contractual requirements.</li></ul> Requirements: <ul><li>Bachelor’s degree (any discipline) or equivalent.</li><li>2 to 6 years’ relevant document control experience, preferably in construction, engineering, manufacturing, oil &amp; gas or EPC project environments.</li><li>Experience supporting project QMS and contractual/client requirements is preferred.</li><li>Software Proficiency: Strong with MS Office (Word, Excel).</li><li>Experience with document management systems/EDMS such as Microsoft SharePoint, Bentley ProjectWise, DocuWare, or similar document control software. Familiarity with PDF tools and CAD/PDF handling.</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>

Responsibilities: <ul><li>Engage with India Leadership to understand emerging risk while providing risk themes and trends that can inform and help improve governance and control awareness.</li><li>Provide IA leadership to the Internal Audit team based in India by motivating and developing individuals to elevate quality and expand capabilities.</li><li>Assist with continuous monitoring activities related to Technology.</li><li>Supervise, manage, and motivate Audit Managers on scheduled audits.</li><li>Oversee audit planning and execution of audits including audit scoping, setting audit objectives, defining audit test steps, performing audit fieldwork and drafting audit reports.</li><li>Review and provide feedback to Audit Managers on the documentation of detailed process walkthroughs performed with management, including the identification of process risks and controls.</li><li>Review and provide feedback on detailed audit work papers performed during fieldwork, including control design and effectiveness testing.</li><li>Ensure Audit Managers have developed and documented clear audit work papers that succinctly articulate the process, risks, controls, test work performed, and conclusions reached.</li><li>Ensure effective and efficient execution of audits in conformance with professional and department quality standards.</li><li>Identify and articulate control gaps or control deficiencies.</li><li>Ensure timeliness of audit work and ensure audit is performed within budget.</li><li>Present audit results to various levels of internal audit leadership, as well as the business organization.</li><li>Contribute to risk assessment process and ongoing business/industry monitoring.</li><li>Maintain internal audit competency through ongoing professional development.</li><li>Oversee career and professional development of direct reports.</li><li>Perform other duties and/or special projects as assigned.</li></ul> Requirements: <ul><li>Bachelors or advanced degree in technology, business, or finance, with a minimum of 10+ years of relevant experience working within audit or a risk management function or minimum 12+ years relevant experience in lieu of a degree</li><li>Bachelor’s degree in Accounting, Auditing, or a technology-related degree with 9+ years of audit experience</li><li>5+ years in technology audit, controls, operations, and/or compliance</li><li>2+ years recent experience managing, supervising, and mentoring individuals</li><li>2+ years recent experience in leading projects and motivating teams</li><li>CISA/CISM/CPA/CIA/CRISC/CISSP certifications</li><li>Ability and flexibility to travel for business as required</li></ul>

Responsibilities: <ul><li>Create and Maintain Strategic Roadmaps: Develop and execute multi-year roadmaps to drive innovation, strengthen security posture, meet regulatory requirements, and streamline IAM operations—specifically for IAM assurance capabilities, control monitoring, and evidence automation.</li><li>Stakeholder Engagement: Build and nurture strong relationships across Security Operations, Technology Teams, Governance, Operational Risk, and Internal Audit, ensuring program alignment, audit readiness, and the ability to clearly demonstrate IAM control effectiveness to stakeholders and regulators.</li><li>Risk and Progress Management: Identify, assess, and mitigate technical and organizational risks while regularly reporting blockers, corrective actions, and program milestones to executive leadership; ensure timely remediation of control gaps and recurring defects.</li><li>Solution Design &amp; Automation: Lead and contribute to designing technical solutions for complex automation use cases, driving operational efficiency and scalability—especially automation to detect, track, and remediate IAM control defects.</li><li>Program Integrity: Ensure standards, policies, and procedures are accurately documented and officially maintained for audit and compliance requirements; recommend updates to IAM standards based on security threats, regulatory expectations, and industry trends.</li><li>Performance Tracking: Define, implement, and monitor Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to measure program maturity and overall effectiveness, including assurance coverage, control pass rates, remediation SLAs, defect recurrence, and reporting timeliness/accuracy.</li><li>Assurance Operations Leadership: Lead assurance activities to track, validate, and remediate key logical access and authentication controls across centralized IAM services (e.g., Active Directory, Oracle LDAP, Beyond Identity) and decentralized implementations as applicable.</li><li>Assurance Reporting Platform Ownership: Manage and evolve the IAM assurance reporting platform(s) used to monitor adherence to company standards, control design, and operational effectiveness; ensure reporting is accurate, resilient, and audit-ready.</li><li>Agile Partnership with Product Owners: Partner with IAM product owners and delivery teams using Agile methodologies to prioritize and implement control improvements, balancing risk reduction with service stability and customer impact.</li><li>Control Evidence &amp; Audit Support: Ensure the organization can efficiently produce high-quality evidence for SOX, PCI, and other examinations; proactively address audit issues with root-cause correction and sustainable control improvements.</li><li>Documentation &amp; Enablement: Oversee creation, maintenance, and review of operational process documentation and end-user/training materials needed to support consistent execution of IAM assurance activities.</li><li>Problem Resolution: Independently resolve technical challenges while escalating issues with clarity when necessary.</li><li>Perform other critical duties or special projects as assigned.</li></ul> Requirements: <ul><li>BS/BA in Computer Science, Information Technology, Cybersecurity, Business Management, or equivalent, plus 10+ years IT experience, OR in lieu of a degree with 12+ years IT experience demonstrating progressive responsibility.</li><li>Minimum 5 years of experience leading multiple IAM service products (e.g., authentication, privileged access, identity governance) and driving outcomes across both centralized and distributed service models.</li><li>Minimum 5 years of experience developing and improving IAM service processes and reporting on IAM service key controls (design and operating effectiveness).</li><li>Minimum 3 years leading operations or assurance teams, including continuous monitoring, issue management, and control remediation.</li><li>At least 2 years working with Agile methodologies in roles such as Product Owner, Scrum Master, or Technical Lead.</li><li>Minimum 2 years of people management experience, leading teams of 2+ engineers or contractors.</li></ul>

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111 loss control Jobs found

Project Manager

Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

Quality Manager

Customer Service Specialist

Document Controller

Manager II – Manufacturing & Process Development Engineering

VP, Senior Audit Manager

VP, IAM Assurance Leader

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111 loss control Jobs found

Project Manager

Associate Director RA & QA

DEA Manager

QMS – Sr Quality & Reliability Engg

Quality Manager

Customer Service Specialist

Document Controller

Manager II – Manufacturing & Process Development Engineering

VP, Senior Audit Manager

VP, IAM Assurance Leader

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.