Quality Assurance Specialist

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 doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

JOB DESCRIPTION

POSITION SUMMARY

The 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 clients 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 clients 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 the presentation for the technical Review Meetings (TRM) and CAC meeting. 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 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/WORK ING CONDITIONS

Normal physical activities.

EDUCATION/COMPETENCE REOUIREMENTS

Qualifications

• Bachelors 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. Outlook Word Excel and PowerPoint

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.