Biologics QA Manager: GMP/QC Method & CMO Oversight

Actalent; United States; Hybrid; USD 83,000 - 110,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401(k) retirement plan

Life Insurance

PTO / Vacation

Job summary

Actalent in Lexington, MA is seeking a Quality Assurance Manager to lead QA/QC activities for biologics manufacturing, focusing on testing, method development, and robust quality systems. You will review batch records, investigations, CAPAs, change controls, and batch disposition for internal and CMOs, ensuring GMP compliance.

The role emphasizes collaboration with QC and AD/QC teams, data-driven decision making, and contributing to QC method development for ongoing clinical-stage molecules.

Qualifications

• Bachelor's degree in life science required.
• Extensive QA/QC experience in biopharma or biologics.
• Experience with GMP environments and QMS.
• Hands-on batch record review experience.
• Experience overseeing CMOs and reviewing their documentation.
• Investigations, CAPA, and change control experience.
• Strong data review and documentation skills.
• Excellent communication across stakeholders.

Responsibilities

• Lead QA/QC activities for biologics manufacturing and QC method development.
• Review internal and external batch records and quality documentation for compliance.
• Perform investigations related to deviations and CAPA with root cause analysis.
• Support batch disposition and timely, compliant release decisions.
• Maintain and improve the Quality Management System (QMS).
• Collaborate with AD/QC teams on testing strategies and data review.
• Contribute to continuous improvement of quality processes and documentation practices.
• Act as an individual contributor with managerial-level responsibility without direct reports.

Skills

QA/QC experience

GMP experience

Batch records

Investigations & CAPA

Change control

CMO oversight

Data review

Cross-functional collaboration

Education

Bachelor's degree in life science

Job description

Actalent in Lexington, MA is seeking a Quality Assurance Manager to lead QA/QC activities for biologics manufacturing, focusing on testing, method development, and robust quality systems. You will review batch records, investigations, CAPAs, change controls, and batch disposition for internal and CMOs, ensuring GMP compliance.

The role emphasizes collaboration with QC and AD/QC teams, data-driven decision making, and contributing to QC method development for ongoing clinical-stage molecules.