Global Clinical QA Leader - Quality Systems & Compliance

AbbVie; Quebec; On-site; CAD 120,000 - 160,000; Full time

Job summary

AbbVie is seeking an experienced RDQA AREA Senior Manager to drive proactive quality management across designated countries/regions and to ensure alignment with One AbbVie Quality System. The role requires leadership in delivering CAPA, change management, and risk mitigation within clinical development contexts.

Reporting to the RDQA Associate Director or Global Director, AREA, this position emphasizes collaboration with development teams, audit readiness, and continuous improvement across

Qualifications

• Bachelor's degree in biology, nursing, pharmacy or related science with 8+ years in biopharma.
• 3 years in leadership positions (people and/or initiatives/projects).
• Strong regulatory and quality systems knowledge.

Responsibilities

• Maintain collaborative relationships with RDQA functions impacting clinical research within designated Affiliates.
• Lead development of risk identification and mitigation strategies for clinical research.
• Ensure compliance with health authority inspections and related regulatory requirements.
• Mentor AREA managers/AREA associates or line management as additional lead responsibility.

Skills

Leadership

Quality systems

Regulatory knowledge

Audit & inspection

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in biology/medical science

Job description

AbbVie is seeking an experienced RDQA AREA Senior Manager to drive proactive quality management across designated countries/regions and to ensure alignment with One AbbVie Quality System. The role requires leadership in delivering CAPA, change management, and risk mitigation within clinical development contexts.

Reporting to the RDQA Associate Director or Global Director, AREA, this position emphasizes collaboration with development teams, audit readiness, and continuous improvement across