Hybrid Lab QA Manager, Product Development (Analytical)

BioSpace; North Chicago (IL); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Job summary

AbbVie is seeking a Hybrid Product Development QA leader to oversee analytical QA for clinical supply releases. You will guide Lab QA, address complex analytical challenges with CMC teams, and drive process improvements.

The role requires strong regulatory knowledge, project management, and clear communication across functions. Candidates should have 6–8 years in QA/analytical sciences, familiarity with API GMP manufacturing, and the ability to lead audits and implement compliance changes across

Qualifications

• 6-8 years experience in QA, analytical sciences, or related field.
• Strong understanding of API and drug product GMP manufacturing in labs.
• Knowledge of US and international quality regulations.
• Experience in project management and coordinating complex activities.
• Excellent oral and written communication; able to present QA positions to leadership.

Responsibilities

• Lead Product Development QA from analytical perspective for clinical supply release.
• Support CMC teams by resolving complex analytical challenges.
• Provide leadership to Lab QA team.
• Drive process improvements by updating policies and procedures.
• Lead QA analytical audits and inspections; serve as QA SME.
• Develop, maintain, and report quality metrics to management.
• Review and approve specifications; manage investigations.
• Ensure compliance with regulations and implement changes.
• Approve laboratory investigations.
• Respond to regulatory requirements across locations.

Education

Bachelor's degree in life sciences or engineering

Master's degree preferred

Job description

AbbVie is seeking a Hybrid Product Development QA leader to oversee analytical QA for clinical supply releases. You will guide Lab QA, address complex analytical challenges with CMC teams, and drive process improvements.

The role requires strong regulatory knowledge, project management, and clear communication across functions. Candidates should have 6–8 years in QA/analytical sciences, familiarity with API GMP manufacturing, and the ability to lead audits and implement compliance changes across