Associate Director RA & QA

QMS – Sr Quality & Reliability Engg

Quality Manager

VP,  Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

Manager, Data Science - Agentic AI

Actuarial Consultant

Lead IT Business Consultant Service - D365

ERP Solution Architect- D365

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>

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: <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>

Responsibilities: <ul><li>Support critical IAM programs; coordinate cross-functionally with IAM teams, Information Security teams and business IT stakeholders to manage the successful delivery of IAM projects</li><li>Deliver on suitable short-term and long-term strategic objectives</li><li>Drive and deliver program issues/risks and resolution, decision logs, communication plans and other program documentation to ensure project goals are achieved and audit traceability is in place</li><li>Engage regularly with key stakeholders on issues/risk and decisions and gather feedback on implementation of solutions impacting the organization</li><li>Establish and support program metrics and evaluation methods to assess program strengths and identify areas for improvement as well as timely reporting of program status throughout its life cycle</li><li>Prepare and present reports for program sponsors and leadership</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent experience; technology or equivalent related field preferred, with a minimum of 6 years of experience in Information Technology OR in lieu of the Bachelors degree, a minimum of 8 years of experience in Information Technology</li><li>Minimum of 5 years of experience managing large scale, cross functional project</li><li>Minimum of 5 years of experience in information technology, with a focus on information security in one or more of the following areas: IAM, security operations, security architecture, policy/governance</li><li>Minimum of 4 years of experience supporting auditors, audit inquiries and ad-hoc reporting</li><li>Solid management skills</li><li>Experience with metrics for assessing and reporting program progress, productivity and variance analysis</li><li>Strong problem solving skills</li><li>Strong oral and written communication (presentation) skills</li><li>Program Management Certified (PMP) preferred</li></ul>

Responsibilities: <ul><li>Leading development of advanced AI Agentic tech.</li><li>Working closely with other data scientists and engineers to design, develop, and deploy AI solutions.</li><li>Collaborating with cross-functional teams to ensure AI solutions are aligned with business goals and customer needs.</li><li>Analyzing large datasets to identify patterns and trends that can inform AI development.</li><li>Communicating findings and insights to stakeholders in a clear and concise manner.</li><li>Staying current with the latest AI and machine learning trends and technologies.</li><li>Mentoring junior data scientists and provide guidance on AI and machine learning best practices</li><li>Driving best practices across our data science functions.</li><li>Setting strategy and team direction, with a clear vision for Data Science.</li><li>Working with product leaders to apply data science solutions..</li><li>Evaluating and creating new frameworks and defining methodologies and governance.</li><li>Leading small- to medium-sized teams (direct or indirect).</li><li>Setting a high bar for model development.</li></ul> Requirements: <ul><li>3+ years of people management experience.</li><li>7+ years of AI/ML experience.</li><li>Significant experience in managing larger technical teams (direct or indirect).</li><li>Have experience in mentoring or training others, acting as a subject matter expert to guide colleagues.</li><li>Be a natural problem solver, able to take a lead in collaborating to resolve issues.</li><li>Have excellent communication skills and the ability to convey information clearly to senior stakeholders.</li><li>Deep understanding of machine learning algorithms, including deep learning, gradient boosting, and random forests.</li><li>Experience working directly with large language models and Transformer based architectures including BERT, RoBERTa, T5 etc.</li><li>Working knowledge of applying recent LLMs including ChatGPT, GPT 3.5, OPT, BLOOM, etc.</li><li>Experience with reinforcement learning, prompt engineering, hallucination mitigation.</li><li>Working understanding of the business risks associated with applying LLM in a business.</li><li>Experience working with large datasets and distributed computing systems (e.g., Hadoop, Spark).</li><li>Strong coding skills in Python or another programming language.</li><li>Excellent communicator, with the ability to translate complex technical concepts to non-technical stakeholders.</li></ul>

Responsibilities: <ul><li>Readiness to the role as per the Retirement career path / skill blocks</li><li>Demonstrate a positive attitude in dealing with changes, reacting to them in a calm, professional manner and actively seeking solutions to any problems which might arise as a result of the changes.</li><li>Adopt a business-friendly writing style when communicating with UK colleagues and drafting advice for clients.</li><li>The content will be focused and concise, with significant actions, information, deadlines and recommendations clearly identified. Avoid using unnecessary colloquialisms, formalities and jargon.</li><li>Prepares original materials (letters, reports, discussion guides) for the lead actuary including first draft of commentary on results</li><li>Fully understands UK pensions legislation, work as an expert scrutiniser on all major work types – Actuarial Valuation / Accounting / Consulting support services / GMP equalisation</li><li>Ability to stand back from detailed calculations, sense-check, draw conclusions and see the work in a broader context of the clients needs and the legislative framework.</li><li>Answers client questions without reliance on the lead actuary and is a strong backup to lead actuary</li><li>Ensures own work and work of junior colleagues is complete and thorough, requiring minimal review from lead actuary</li><li>Identifies and implements improvements to the various processes</li><li>Champions of new ideas and initiatives that deliver strategic results</li><li>Plan and execute technical meetings and training as per the teams requirement for the Individual contributor roles</li><li>Create an open, collaborative, and engaging team environment&nbsp;</li></ul> Requirements: <ul><li>Strong analytical and mathematical skills, with a keen eye for detail</li><li>Ability to effectively communicate the team goals and drive business results</li><li>Understands the professional requirements and quality standards for UK work</li><li>Strong organizational skills to manage multiple projects and deadlines efficiently</li><li>Ability to work in a team and collaborate effectively with colleagues from diverse backgrounds</li><li>An expert in one or more of the specialist areas – valuation, accounting, client extension work, risk &amp; modelling, GMP equalisation, cash equivalent transfer value – but will have a general understanding of all the work and the ability to adapt to new work.&nbsp;</li></ul>

Responsibilities: Lead Consultant Responsibilities <ul><li>Provide oversight and ensure solutions align with the broader business architecture, avoiding siloed approaches.</li><li>Ensure modifications to shared functionalities are evaluated holistically to avoid conflicting changes.</li><li>Establish and enforce best practices, including clear documentation, intuitive configurations, and optimized parameter settings.</li><li>Challenge business requirements to ensure cost-effective and value-driven solutions.</li><li>Harmonize design across multiple consultants, teams, and projects to enhance consistency and efficiency.</li></ul> Work closely with the ERP Solution Architect to ensure: <ul><li>Alignment with Microsoft’s roadmap and strategic ERP direction.</li><li>Architectural consistency across process areas and technical solutions.</li><li>Risk assessment for system-critical modifications.</li><li>Data migration strategies align with the overall system architecture.</li><li>Identification and resolution of conflicts with other processes, modifications, or upcoming Microsoft updates.</li></ul> Service-Specific Responsibilities <ul><li>Lead solution delivery for Service processes based on D365 Finance and Operations modules, covering:</li></ul> <ul><li>Project Management and Accounting module</li><li>HSO Service Management module</li><li>Intercompany chain</li><li>Sales orders and Return orders management</li><li>Advanced Warehousing (incl. Batch and Serial tracking)</li><li>Act as the primary owner and project lead for Service-related ERP implementations and enhancements.</li><li>Analyze business needs and develop solution concepts.</li><li>Design, configure, and document ERP solutions.</li><li>Provide detailed requirements for the development team.</li></ul> Requirements: <ul><li>Extensive experience (min. 5 years) as a Microsoft D365 ERP F&amp;O IT Consultant with a focus on Service.</li><li>Agile mindset and ability to work independently.</li><li>Strong analytical and problem-solving skills, with the ability to think critically under pressure.</li><li>Excellent communication skills, capable of engaging with stakeholders at all levels.</li><li>Leadership skills, including the ability to mentor consultants and drive best practices across teams.</li><li>Fluent in English.</li></ul>

Responsibilities: Design Authority Responsibilities <ul><li>Validate solution designs and ensure architectural consistency across modules and projects.</li><li>Conduct detailed design reviews for GAPs, FDDs, and technical specifications before Design Authority approval.</li><li>Identify integration and performance risks early in the design phase and guide mitigation strategies.</li><li>Support the Design Authority in ensuring end-to-end solution coherence, especially across Finance, SCM, Project Ops, and Sales.</li><li>Work closely with the Domain Architect ERP to ensure:</li><li>Alignment with our client ERP domain architecture and roadmap.</li><li>Adherence to Microsoft’s D365 best practices and upgrade paths.</li><li>System-critical modifications are designed and implemented with risk awareness.</li><li>Data migration and interface designs follow architectural standards.</li><li>Collaborate with Lead Consultants and Developers to ensure designs are feasible, efficient, and maintainable.</li></ul> Solution Delivery Responsibilities <ul><li>Provide hands-on architecture support to delivery teams during all project phases (Blueprint, Build, Test, Deploy).</li><li>Define and communicate solution patterns and reusable components to increase delivery efficiency.</li><li>Oversee the technical integrity of ERP solutions and their alignment with the target architecture.</li><li>Support complex problem-solving, performance optimization, and integration design.</li><li>Ensure compliance with our client ERP governance, documentation, and security standards.</li><li>Act as the quality gate for designs entering the Design Authority approval process.</li></ul> Requirements: <ul><li>Minimum 8 years of experience in Microsoft D365 ERP solution design and implementation, with deep knowledge across multiple modules (Finance, SCM, or Project Operations).</li><li>Proven experience as a Solution Architect or Senior Consultant in large-scale international ERP programs.</li><li>Strong understanding of D365 data models, integrations (Data Management Framework, Dual Write, APIs), and reporting (SSRS, Power BI).</li><li>Experience in solution governance, design validation, and architecture documentation.</li><li>Familiarity with Azure integration services, Power Platform, and lifecycle management tools (LCS).</li><li>Agile mindset, excellent problem-solving skills, and strong delivery orientation.</li><li>Ability to collaborate across functional and technical teams, ensuring alignment between design, build, and deployment.</li><li>Excellent communication skills and fluency in English (both written and verbal).</li></ul>

Skills

Industry

Location

Jobtitle

99 risk base inspection facilitator Jobs found

Associate Director RA & QA

QMS – Sr Quality & Reliability Engg

Quality Manager

VP, Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

Manager, Data Science - Agentic AI

Actuarial Consultant

Lead IT Business Consultant Service - D365

ERP Solution Architect- D365

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

99 risk base inspection facilitator Jobs found

Associate Director RA & QA

QMS – Sr Quality & Reliability Engg

Quality Manager

VP, Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

Manager, Data Science - Agentic AI

Actuarial Consultant

Lead IT Business Consultant Service - D365

ERP Solution Architect- D365

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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