Global Senior Manager, Clinical Quality Assurance

AbbVie Inc.; Greenlawn (NY); On-site; USD 130,000 - 180,000; Full time

Job summary

AbbVie Inc. is seeking an experienced RDQA AREA Senior Manager to drive quality excellence across designated countries and the region, aligning with the One AbbVie Quality System and ensuring readiness for regulatory submissions.

You will report to the AREA leaders and partner with clinical development teams to reduce risk and accelerate access to therapies. The role requires 8+ years in biopharmaceutical/medical device quality functions, strong leadership, and the ability to travel up to 35%.

Qualifications

• Bachelor's degree with 8+ years in biopharmaceutical/medical device quality assurance, compliance, regulatory affairs, or related development functions; 3+ years in leadership roles.
• Strong understanding of local and global regulatory requirements and risk-based oversight.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Excellent written and oral communication and influencing skills.
• Ability to lead cross-functional teams and collaborate across global/local levels.
• Willingness to travel up to 35%.

Responsibilities

• Maintain collaborative relationships with RDQA functions impacting clinical research in designated Affiliates.
• Advance AbbVie Quality System and drive quality excellence to achieve first-pass approvals.
• Oversee quality and compliance in a regulated environment per AbbVie policies and regional standards.
• Develop risk identification/mitigation strategies for clinical research activities.
• Set quality measures to achieve RDQA goals and drive regional quality strategy.
• Provide governance and ensure readiness for Health Authority inspections.
• Audit and inspection planning, reporting, and corrective action management.
• Mentor AREA Managers/Associates and provide leadership in added responsibilities.

Skills

Leadership

Quality systems

Regulatory affairs

Auditing & inspections

Risk management

Cross-functional collaboration

Communication skills

Travel willingness

Multilingual (desirable)

Education

Bachelor's degree in Biology, Nursing, Pharmacy or related life science

Job description

AbbVie Inc. is seeking an experienced RDQA AREA Senior Manager to drive quality excellence across designated countries and the region, aligning with the One AbbVie Quality System and ensuring readiness for regulatory submissions.

You will report to the AREA leaders and partner with clinical development teams to reduce risk and accelerate access to therapies. The role requires 8+ years in biopharmaceutical/medical device quality functions, strong leadership, and the ability to travel up to 35%.