QA Leader: Regulatory Compliance & Inspections

AbbVie; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Assurance Manager to support manufacturing processes across pharmaceutical products, medical devices, cosmetics, and biologics. You will translate strategy into tactical objectives and lead a team of QA professionals to ensure compliance with regulatory requirements and internal standards.

The role requires excellent communication with management, hands‑on CAPA implementation, and the ability to deliver strategic plans while managing day‑to‑day QA operations at the

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related technical field preferred.
• 8+ years in quality assurance, quality oversight, or related experience.
• Leadership of technical professionals and cross‑functional teams.
• Strong knowledge of QA systems and regulatory requirements (FDA/EMA/ICH).

Responsibilities

• Provide direction to QA staff including hiring, performance feedback and development.
• Direct development of quality policies meeting regulatory and company standards.
• Maintain expertise on regulatory requirements and lead compliance at the site.
• Interface with FDA and other regulators during inspections.
• Review deviations and implement CAPA to reduce quality events.
• Produce quality metrics for senior management and drive improvements.
• Promote quality awareness and compliance across the organization.

Skills

Leadership

Regulatory knowledge

GMP compliance

Cross-functional collaboration

Education

Bachelor's degree in a technical/scientific field

Job description

AbbVie is seeking a Quality Assurance Manager to support manufacturing processes across pharmaceutical products, medical devices, cosmetics, and biologics. You will translate strategy into tactical objectives and lead a team of QA professionals to ensure compliance with regulatory requirements and internal standards.

The role requires excellent communication with management, hands‑on CAPA implementation, and the ability to deliver strategic plans while managing day‑to‑day QA operations at the