Site QA & Regulatory Leader — Compliance Excellence

Allergan; Worcester (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie in Worcester, MA, seeks a senior quality leader to oversee site Quality Operations, ensuring regulatory compliance and successful inspections. You will drive continuous improvement, manage a cross-functional team, and partner with global functions to deliver compliant products.

The role requires extensive GMP/biopharma experience, Lean Six Sigma, and strong strategic leadership to support filings and risk management. This is a high-impact, leadership-focused position.

Qualifications

• 15+ years’ experience in GMP pharmaceutical/biologics/medical device manufacturing
• 5+ years of progressive people leading experience
• Lean Six Sigma Black Belt certification preferred
• Advanced knowledge of cGMPs, GXP regulatory standards
• Ability to manage multiple projects with global teams
• Strong communication and influencing skills

Responsibilities

• Oversee Compliance and Regulatory activities at site operations
• Lead a team responsible for a broad range of activities including inspections and audits
• Support CMC filing and responses and market expansion filings
• Own client quality agreements and risk management programs
• Ensure site management review program effectiveness
• Provide inspirational leadership and develop talent within the team
• Promote AbbVie culture and succession planning for Site Quality Director

Skills

Strategic leadership

Regulatory knowledge

Project management

Communication

Lean Six Sigma

Cross-functional collaboration

Change management

Education

Bachelor’s degree in Engineering/ Chemistry/ Microbiology or Science related field

Job description

AbbVie in Worcester, MA, seeks a senior quality leader to oversee site Quality Operations, ensuring regulatory compliance and successful inspections. You will drive continuous improvement, manage a cross-functional team, and partner with global functions to deliver compliant products.

The role requires extensive GMP/biopharma experience, Lean Six Sigma, and strong strategic leadership to support filings and risk management. This is a high-impact, leadership-focused position.