JOB DESCRIPTION

POSITION SUMMARY

The Compliance Specialist ensures that pharmaceutical operations comply with Bausch Inc. standards and external regulatory requirements. This role is responsible for supplier management, internal and external audits, supporting of regulatory and client inspections hosting, quality agreements, drug license maintenance, new product introduction, and product transfers. The position supports continuous improvement initiatives, risk mitigation, and regulatory inspection readiness.

MAJOR AREAS OF RESPONSIBILITY

Supplier Management

• Maintain and monitor the Approved Supplier List (ASL) and ensure supplier qualifications are updated.
• Conduct supplier audits and internal audits to ensure compliance with GXP, applicable regulations and adherence to the Bausch Quality standards.
• Collaborate with cross-functional teams during the new supplier’s introduction.
• Track and follow up on supplier CAPAs and performance metrics (annual supplier evaluation).
• Draft, Negotiate and maintain Quality Agreements with clients, suppliers and service providers.

Audit Coordination

• Schedule, coordinate and execute internal audits in accordance with the annual audit program.
• Support external audits with third parties, ensuring readiness and timely responses.
• Issue audit reports and approve CAPA plan from suppliers.
• Maintain audit records and ensure timely closure of audit actions and adherence to the annual schedule.

Regulatory Audit Hosting

• Provide support on regulatory inspections (e.g., FDA, EMA, Health Canada) and clients audits.
• Coordinate cross-functional teams to ensure inspection readiness.

Quality Agreements & Drug Licenses

• Develop, review, and maintain Quality Agreements with suppliers, contractors, and partners. Ensure agreements are aligned with regulatory expectations and internal Bausch Inc. quality standards.
• Support the maintain and update drug establishment licenses, product licenses, and related regulatory documentation.

New Product Introduction & Product Transfer

• Support compliance activities related to the introduction of new products, including documentation, supplier onboarding, and regulatory alignment.
• Participate in cross-functional project teams to ensure quality and compliance requirements are met during product transfers between sites or partners.
• Review and approve transfer documentation, including validation protocols, reports, risk assessments, and change controls.
• Ensure regulatory and quality requirements are integrated into project timelines and deliverables.

Compliance & Documentation

• Ensure compliance with applicable regulations, company policies, and industry standards.
• Support the development and revision of SOPs, policies, and quality documentation.
• Participate in quality risk assessments and continuous improvement initiatives.

MANAGEMENT RESPONSIBILITIES

Not applicable

OTHER DUTIES

Not applicable

LEVEL OF AUTHORITY

• Responsible of the CQMS.
• Responsible of BHCI's DEL, SL and MDEL.

PHYSICAL DEMANDS/WORK ING CONDITIONS

Normal physical activities.

EDUCATION/COMPETENCE REOUIREMENTS

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field.
• 5+ years of experience in pharmaceutical compliance, quality assurance, or auditing.
• Strong knowledge of GMP, GDP, ICH guidelines, Health Canada and FDA and regulatory requirements.
• Experience with supplier qualification, audit hosting, quality agreements, and product lifecycle management.
• Familiarity with drug license maintenance and regulatory documentation.
• Experience in new product introduction and product transfer projects is an asset.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Administrative/Managerial Competencies: Results oriented; 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