Strategic QA Compliance & Regulatory Director

ABBVIE; Worcester (MA); On-site; USD 161,000 - 305,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a senior leader to drive Site Quality Operations, ensuring regulatory compliance and inspection readiness. You will oversee a team delivering high-quality, compliant products and manage risk, audits, and quality agreements across global operations.

The role emphasizes strategic project management, cross-functional collaboration, and development planning, with a view toward succession for Site Quality Director within a broad AbbVie network.

Qualifications

• Bachelor’s degree is required; preferably in Engineering, Chemistry, Microbiology or Science related field.
• 15+ years’ experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5+ years of progressive people leading experience required.
• Lean Six Sigma Black Belt certification is preferred.
• Skilled in strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
• Advanced knowledge of cGMPs, GXP, and other regulatory standards and guidelines applicable to medical device/bio/pharmaceutical industry.
• Ability to manage multiple projects and work with global cross-functional teams.
• Experience in facilitation, negotiation, and influencing skills. Ability to drive change.
• Strong verbal and written communication skills needed; excellent interpersonal skills required.

Responsibilities

• Oversight of Compliance and Regulatory activities at the site operations level, specifically leadership of a team responsible for a broad range of activities.
• Inspection readiness and execution for regulatory agencies; Audit readiness and execution for client audits.
• Lead internal self-inspection program to maintain compliance with AbbVie quality requirements and global standards.
• Support CMC filing and response to questions; provide data and support for market expansion filings.
• Ownership of client quality agreements.
• Ownership of risk management programs.
• Facility related support such as pest control, engineering updates, and non-process related systems.
• Ownership of the site management review program.
• Leading and inspiring a team of individuals, providing an exceptional employee experience through clear communication, sensible goal setting, succession planning and development planning.
• Demonstrating and Promoting AbbVie culture and Ways of Working.
• Intention to be part of succession plan for Site Quality Director and open to possible opportunities in the broader AbbVie network.

Skills

Leadership

GMP knowledge

Quality systems

Regulatory filings

Cross-functional collaboration

Communication skills

Lean Six Sigma Black Belt

Education

Bachelor’s degree in Engineering/Science

Job description

AbbVie is seeking a senior leader to drive Site Quality Operations, ensuring regulatory compliance and inspection readiness. You will oversee a team delivering high-quality, compliant products and manage risk, audits, and quality agreements across global operations.

The role emphasizes strategic project management, cross-functional collaboration, and development planning, with a view toward succession for Site Quality Director within a broad AbbVie network.