Regulatory Quality Director — Site Operations

Biopharma Careers; Maryland; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a senior Site Quality Operations leader to drive regulatory compliance, continuous improvement, and site quality system governance. You will oversee a diverse team responsible for inspections, audits, and risk management to ensure high-quality, compliant products for patients.

With 15+ years in GMP settings and a Black Belt, you will influence cross-functional teams globally, shape strategy, and contribute to succession planning for site leadership within AbbVie.

Qualifications

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

Responsibilities

• Oversight of Compliance and Regulatory activities at site operations level; lead a team.
• Ensure inspection readiness and client audit readiness.
• Support CMC filings and responses; assist with market expansion filings.
• Own risk management programs and site management review process.
• Promote AbbVie culture and leadership development; succession planning.

Skills

GMP / regulatory knowledge

People leadership

Quality Systems

Strategic planning

Cross-functional collaboration

Audit readiness

Education

Bachelor's degree in a Science/Engineering field

Job description

AbbVie is seeking a senior Site Quality Operations leader to drive regulatory compliance, continuous improvement, and site quality system governance. You will oversee a diverse team responsible for inspections, audits, and risk management to ensure high-quality, compliant products for patients.

With 15+ years in GMP settings and a Black Belt, you will influence cross-functional teams globally, shape strategy, and contribute to succession planning for site leadership within AbbVie.