Product Development QA Manager

Allergan; Chicago, Northern (IL, KY); Hybrid; USD 95,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Job summary

AbbVie is seeking a QA professional to support clinical supplies by reviewing batch records, ensuring GMP compliance, and facilitating timely product releases. You will collaborate across functions, lead audits, and drive quality improvements while maintaining schedules and audit readiness.

The role requires deep knowledge of regulatory requirements, strong problem-solving skills, and the ability to mentor peers in a fast-paced environment.

Qualifications

• Bachelor’s degree in life sciences or engineering, or equivalent experience.
• 6+ years in Quality Assurance, production, or related pharmaceutical field; advanced degree may substitute experience.
• Experience with GMP (D, EU, US) and regulatory audits is preferred.
• Ability to defend quality positions and solve complex technical issues.

Responsibilities

• Review and approve batch records and release documentation.
• Write, review, and approve procedures and related documents.
• Lead audits by regulatory bodies, customers, and R&D GxP Compliance.
• Assess regulatory changes and implement procedural updates.
• Provide management support and act as backup for routine activities.
• Support daily product release activities and drive process improvements.
• Lead or participate in project teams for product development.
• Monitor process effectiveness and quality of project work.

Skills

Quality assurance

Regulatory compliance

Problem solving

Team collaboration

Education

Bachelor's degree in life sciences/engineering

Master's degree preferred

Job description

AbbVie is seeking a QA professional to support clinical supplies by reviewing batch records, ensuring GMP compliance, and facilitating timely product releases. You will collaborate across functions, lead audits, and drive quality improvements while maintaining schedules and audit readiness.

The role requires deep knowledge of regulatory requirements, strong problem-solving skills, and the ability to mentor peers in a fast-paced environment.