Global Safety & Regulatory Quality Lead

Allergan; Waltham (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie in the United States is seeking a Senior Manager to lead Safety, Medical & Regulatory Quality within RDQA. You will guide quality oversight across safety, RA, and MA activities for drug, device, and cosmetic portfolios, partnering with global teams and external partners.

The role centers on building quality systems, enabling inspections, and delivering compliant, high-integrity data. Strong leadership and communication are essential for success.

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 in pharma.
• 5 years of experience in Quality Assurance.
• Strong analytical skills and ability to organize work and collaborate with partners.
• Extensive knowledge of quality standards and worldwide regulatory requirements for safety, RA or MA.
• Able to adapt to changing assignments and work autonomously in a fast-paced environment.
• Project management, interpersonal and communication skills with ability to influence.
• Able to work independently or as part of a team.
• Strong communication and interpersonal skills.

Responsibilities

• Contribute to continuous compliance with global regulations and regulatory inspections.
• Demonstrate AbbVie's Ways of Working and Leadership Attributes.
• Fulfil expectations to ensure organizational success with open communication.
• Support holistic quality assurance for GxP activities and interfacing with cross-functional teams.
• Determine and evaluate risks, proposing mitigations for compliance.
• Support business process owners to integrate quality in process development.
• Participate in front/back-room Regulatory Authority inspection activities for safety, RA and MA topics.
• Serve as a partner for consultation regarding worldwide safety, regulations and corporate policies.
• Generate, analyze and report metrics on compliance status; escalate issues timely.
• Develop and implement systems to support RDQA quality strategies and audits.
• Drive change and efficiency through feedback and strong collaboration.
• Model AbbVie Behaviors in all responsibilities.

Skills

Pharmacovigilance

Regulatory affairs

Quality assurance

GxP knowledge

Project management

Communication

Leadership

Analytical skills

Education

Bachelor's degree in biology, nursing, pharmacy or science-based field

Job description

AbbVie in the United States is seeking a Senior Manager to lead Safety, Medical & Regulatory Quality within RDQA. You will guide quality oversight across safety, RA, and MA activities for drug, device, and cosmetic portfolios, partnering with global teams and external partners.

The role centers on building quality systems, enabling inspections, and delivering compliant, high-integrity data. Strong leadership and communication are essential for success.