Global RDQA Senior Manager, Clinical Quality Assurance

AbbVie; Toronto; On-site; CAD 120,000 - 170,000; Full time

Job summary

AbbVie is seeking an experienced RDQA AREA Senior Manager to drive proactive quality management across designated countries and regions. You will lead the execution of quality systems, CAPA, risk management and inspections to support global clinical development and regulatory submissions.

You will collaborate with clinical development leaders to advance the One AbbVie Quality System, ensure compliance, and foster crossfunctional partnerships. Travel up to 35% may be required.

Qualifications

• Bachelor's degree in Biology, Nursing, Pharmacy or related field.
• 8+ years in biopharma/medical device quality, compliance, regulatory affairs or clinical research.
• 3+ years in leadership positions (people and/or initiatives/projects).

Responsibilities

• Maintain close, collaborative relationships with RDQA functions in designated Affiliates and region.
• Advance AbbVie Quality System, drive quality excellence, and seek first-pass approvals.
• Oversee quality and compliance in a regulated environment following AbbVie policies and regional standards.
• Develop risk identification and mitigation strategies for clinical research activities.
• Establish quality measures to achieve RDQA goals and regulatory preparedness.
• Mentor AREA Managers/Associates or line management as needed.

Skills

Leadership

Quality Assurance

Regulatory Affairs

Clinical Research

Audit & Compliance

Risk Management

Collaboration

Education

Bachelor's degree in Biology/Nursing/Pharmacy or related field

Job description

AbbVie is seeking an experienced RDQA AREA Senior Manager to drive proactive quality management across designated countries and regions. You will lead the execution of quality systems, CAPA, risk management and inspections to support global clinical development and regulatory submissions.

You will collaborate with clinical development leaders to advance the One AbbVie Quality System, ensure compliance, and foster crossfunctional partnerships. Travel up to 35% may be required.