QA Compliance and Regulatory Director
AbbVie
August 20, 2026
On-site
Worcester, MA
$160,500 - $305,000 USD yearly
Operations
Responsibilities:
- Provide site Quality Operations leadership to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System.
- Oversight of Compliance and Regulatory activities at the site operations level, including inspection readiness/execution for regulatory agencies and audit readiness/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.
- Own client quality agreements, risk management programs, facility related support (e.g., pest control, engineering updates, non-process systems), and the site management review program.
- Lead and inspire a team; ensure an exceptional employee experience through communication, goal setting, succession planning, and development planning.
- Demonstrate and promote AbbVie culture and Ways of Working.
- Participate in succession plan for Site Quality Director; open to broader AbbVie network opportunities.
Qualifications:
- Bachelor’s degree required; preferably Engineering, Chemistry, Microbiology, or a related Science field.
- 15+ years’ experience in GMP pharmaceutical/biologics and/or medical device manufacturing; 5+ years progressive people leadership experience required.
- Lean Six Sigma Black Belt certification preferred.
- Skilled in strategy development and project initiation, selection, coordination, and management; ability to solve unique problems.
- Advanced knowledge of cGMPs, GXP, and other applicable regulatory standards.
- Ability to manage multiple projects and work with global cross-functional teams.
- Facilitation, negotiation, influencing skills; ability to drive change.
- Strong verbal/written communication and excellent interpersonal skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.
- Provide site Quality Operations leadership to support strategic initiatives, product filings, continuous improvement, and management of the site Quality System.
- Oversight of Compliance and Regulatory activities at the site operations level, including inspection readiness/execution for regulatory agencies and audit readiness/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.
- Own client quality agreements, risk management programs, facility related support (e.g., pest control, engineering updates, non-process systems), and the site management review program.
- Lead and inspire a team; ensure an exceptional employee experience through communication, goal setting, succession planning, and development planning.
- Demonstrate and promote AbbVie culture and Ways of Working.
- Participate in succession plan for Site Quality Director; open to broader AbbVie network opportunities.
Qualifications:
- Bachelor’s degree required; preferably Engineering, Chemistry, Microbiology, or a related Science field.
- 15+ years’ experience in GMP pharmaceutical/biologics and/or medical device manufacturing; 5+ years progressive people leadership experience required.
- Lean Six Sigma Black Belt certification preferred.
- Skilled in strategy development and project initiation, selection, coordination, and management; ability to solve unique problems.
- Advanced knowledge of cGMPs, GXP, and other applicable regulatory standards.
- Ability to manage multiple projects and work with global cross-functional teams.
- Facilitation, negotiation, influencing skills; ability to drive change.
- Strong verbal/written communication and excellent interpersonal skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.