Senior PDQA Manager - Quality Assurance for Clinical Supply

BioSpace; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Long-term incentive programs

Job summary

AbbVie is seeking a seasoned QA professional to support batch disposition and ensure high-quality clinical supplies aligned with global regulatory standards. The role requires interaction with multiple functional teams, mentorship, and proactive resolution of batch documentation issues to maintain schedules and ensure material availability.

Responsibilities include reviewing records, contributing to audits, and implementing process improvements across PDQA.

Qualifications

• Bachelor's degree in life sciences, chemistry, or engineering or equivalent experience.
• 6+ years in QA, production, or testing of APIs, drug products, or related healthcare fields.
• Strong problem-solving skills and ability to defend quality positions.

Responsibilities

• Review and approve batch records and release entries.
• Lead audits conducted by regulatory agencies and customers.
• Review regulatory changes and update SOPs accordingly.
• Provide management support and backup for routine QA activities.
• Support daily product release activities and drive process improvements.

Skills

Quality Assurance

GxP Compliance

Analytical Sciences

Global GMP

Education

Bachelor's degree

Master's degree preferred

Job description

AbbVie is seeking a seasoned QA professional to support batch disposition and ensure high-quality clinical supplies aligned with global regulatory standards. The role requires interaction with multiple functional teams, mentorship, and proactive resolution of batch documentation issues to maintain schedules and ensure material availability.

Responsibilities include reviewing records, contributing to audits, and implementing process improvements across PDQA.