Senior Quality Assurance Specialist

Job Location: Laval, CAN Job Requisition ID: 14822 Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. Position details Position title: Sr. COMPLIANCE SPECIALIST Reports to (title): Compliance & Project Supervisor Date: November 04, 2025 Location Code (Corporate): Laval HR Position Code (Corporate): N/A Position Summary The Senior Compliance Specialist serves as a key subject matter expert on cGMP and regulatory compliance requirements, ensuring consistent interpretation and application across Contract Manufacturing Organizations (CMOs) and internal manufacturing sites. This role plays a pivotal part in maintaining inspection readiness, managing regulatory notifications, and supporting new product launches. The Senior Compliance Specialist ensures that all activities align with global Bausch quality standards and regulatory expectations to uphold product quality and compliance excellence. Major Areas of Responsibility Regulatory Compliance Expertise: Provide expert advice on cGMP and regulatory compliance requirements to ensure accurate, fit-for-purpose interpretation and application across CMOs, manufacturing sites and GMP suppliers. Regulatory Agency Notifications: Prepare, coordinate, and manage timely communications and notifications to regulatory authorities as required. Recall Coordination: Lead and oversee product recall activities to ensure full compliance with regulatory and internal company procedures. Product Launch Support: Collaborate with Compliance Specialists and cross-functional teams to ensure timely and compliant new product launches. CMO and Client Quality Agreements: Review, negotiate, and maintain Quality Agreements with CMOs and clients to ensure alignment with company quality standards and regulatory expectations. Inspection Readiness: Drive and maintain inspection readiness across the site and CMOs, ensuring preparedness for regulatory, client, and corporate inspections. Due Diligence: Conduct compliance assessments and due diligence activities to ensure that any external partner aligns with Bausch quality, regulatory, and business standards. Escalation Management: Coordinate escalated quality events, including the preparation of presentations for the technical Review Meetings (TRM) and CAC meetings. Ensure timely follow-up on investigation closure and effective implementation of CAPAs. Technical Support: Provide technical and compliance expertise to resolve critical quality issues in collaboration with cross-functional teams. External Audits: Plan, coordinate, execute, and support external audits program for CMOs and GMP suppliers to ensure ongoing compliance with regulatory and company standards. Additional Duties: Perform other responsibilities as assigned by the manager to support department and organizational objectives. Management and Other Duties Management Responsibilities: Ability to support cross-functional teams and lead complex projects under tight timelines. Other Duties: Not applicable Level of Authority: Not applicable Physical Demands / Working Conditions Normal physical activities. Education / Competence Requirements Qualifications Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field (advanced degree preferred). Minimum 7+ years of experience in pharmaceutical or biotech industry with strong knowledge of cGMP and regulatory requirements. Proven experience in compliance, auditing, and inspection readiness. Strong communication and negotiation skills for managing CMOs and regulatory interactions. Ability to support cross-functional teams and lead complex projects under tight timelines. Administrative/Managerial Competencies : Results and teamwork oriented. Interpersonal Skills/Competencies: Meticulous, efficient, consistent, reliable and persuasive. Other: Excellent oral and written communication skills in French and English. Proficiency in Outlook, Word, Excel and PowerPoint. Disclaimer “The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, skills, and competencies required of personnel so classified.” Direct report: N/A Indirect report: N/A We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration. #J-18808-Ljbffr