Senior Manager, Safety, Medical & Regulatory Quality — Hybrid

Job overview

The Senior Manager, Safety, Medical & Regulatory Quality role is described as hybrid and is listed in Florham Park, NJ. Compensation is not specified. The role supports AbbVie’s Research & Development Quality Assurance organization and its mission to deliver innovative medicines and solutions. The position contributes to independent quality oversight of safety activities across AbbVie’s research and development and other business functions. It supports regulatory compliance, patient safety, data integrity, inspection readiness, and quality excellence through technical consultation, risk assessment, collaboration, and quality systems work.

What you'll do

• Support continuous compliance with global regulations and AbbVie policies
• contribute to quality assurance for applicable GxP activities
• assess compliance risks and propose mitigations
• support business process owners in integrating quality into processes
• participate in regulatory authority inspections
• consult on safety, regulatory affairs, medical affairs, CAPA, and quality disciplines
• analyze and report compliance metrics
• contribute to global QA systems, strategies, and audit programs
• provide feedback and recommendations to improve processes.

What we're looking for

Skills & competencies

senior manager

safety quality

medical affairs

regulatory affairs

quality assurance

gxp

pharmacovigilance

inspection readiness

hybrid

florham park nj

abbvie

biopharmaceuticals

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid time off, medical/dental/vision insurance, 401(k), and eligibility for long-term incentive programs.

Why this role

The posting describes a hybrid role and eligibility for paid time off, medical, dental, and vision insurance, 401(k), and long-term incentive programs.

About the employer

AbbVie is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.