QA Compliance and Regulatory Director
$160,500–$305,000 year
HybridWorcester, Massachusetts, United States
Job Summary
Lead site Compliance and Regulatory activities by overseeing inspection readiness for regulatory agencies and client audits, while driving internal audit programs to maintain cGMP adherence. Manage the site Quality System, including ownership of risk management, facility support for engineering updates, and the site management review program. Support CMC filings and market expansion responses with data and analysis. Lead a team through clear communication, goal setting, and succession planning to ensure high-quality, compliant product delivery. This role supports strategic initiatives for product filings and continuous improvement within AbbVie's immunology, oncology, and neuroscience therapeutic areas.
Required Qualifications
- Bachelor's degree
- 15+ years' experience in GMP pharmaceutical, biologics and/or medical device manufacturing
- 5+ years of progressive people leading experience
- 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
- Excellent interpersonal skills
- Intention to be part of succession plan for Site Quality Director
- Open to possible opportunities in the broader AbbVie network
Desired Qualifications
- Bachelor's degree, preferably in Engineering, Chemistry, Microbiology or Science related field
- Lean Six Sigma Black Belt certification
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