Senior Manager, Safety & Regulatory Quality - Hybrid

ABBVIE; Florham Park (NJ); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie in the United States seeks a Senior Manager, Safety, Medical & Regulatory Quality for a hybrid work arrangement. You will lead global QA oversight of safety activities across R&D and non-R&D functions, collaborating with safety, regulatory affairs and medical affairs to ensure compliant, inspection-ready programs.

The role emphasizes quality leadership, cross-functional partnership, and the ability to drive continuous improvement in pharmacovigilance, compliance and CAPA activities within

Qualifications

• Bachelor's degree preferably in Biology, Nursing, Pharmacy, or other science-based degree.
• 5 years of experience in pharmacovigilance, regulatory affairs and/or quality assurance supporting those areas.
• 5 years of experience in Quality Assurance.
• Strong analytical skills and the ability to interact with RDQA partners and external partners.
• Knowledge of worldwide regulatory requirements and industry best practices relating to safety, RA or MA.

Responsibilities

• Contribute to continuous compliance with global regulations and regulatory preparedness for inspections.
• Demonstrate AbbVie Ways of Working and leadership attributes with collaboration.
• Support a holistic quality assurance model for GxP activities and ensure integration with interfacing GxPs.
• Deliver innovative quality strategies and solutions to support compliance issues and audit findings.
• Participate in regulatory inspections to enable successful safety, RA and MA topics.

Skills

Pharmacovigilance

Regulatory Affairs

Quality Assurance

Leadership

Data analysis

Education

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

Job description

AbbVie in the United States seeks a Senior Manager, Safety, Medical & Regulatory Quality for a hybrid work arrangement. You will lead global QA oversight of safety activities across R&D and non-R&D functions, collaborating with safety, regulatory affairs and medical affairs to ensure compliant, inspection-ready programs.

The role emphasizes quality leadership, cross-functional partnership, and the ability to drive continuous improvement in pharmacovigilance, compliance and CAPA activities within