Biologics QA & Compliance Lead

Actalent; Lexington (MA); Hybrid; USD 83.000 - 110.000; Vollzeit

Zusammenfassung

Actalent in Lexington, MA is seeking a Quality Assurance Manager to lead QA/QC activities for biologics manufacturing. The role focuses on testing, method development, and maintaining robust quality systems, ensuring GMP compliance and batch disposition across internal and external CMOs.

You will review batch records, investigations, CAPAs, and change controls, collaborate with AD/QC teams, and drive continuous improvement of QC methods and data review practices in a hybrid onsite setting.

Qualifikationen

• 10-15 years of experience in QA/QC within life sciences or biopharma.
• BS/BA in a life science discipline.
• Extensive GMP/QMS exposure in biologics or drug manufacturing.
• Hands-on batch record review and adherence to regulatory requirements.
• Experience managing CMOs and overseeing external quality documentation.
• Strong investigations, root cause analysis, and CAPA implementation.
• Familiar with change control processes and QC method development.
• Excellent cross-functional communication and collaboration skills.

Aufgaben

• Support QC activities including product testing, stability control, and method development.
• Review batch records for internal operations to ensure GMP compliance.
• Review external CMOs' batch records and quality documentation for compliance.
• Investigations and CAPAs with root cause analysis and effective corrective actions.
• Assist batch disposition decisions by reviewing data and quality records.
• Maintain and improve the quality management system (QMS).
• Contribute to QC method development and review for biologics.
• Support change control activities including initiation and documentation.
• Collaborate with QC and AD/QC teams on testing strategies and data review.
• Provide quality oversight for CMOs and external partners.
• Support biologics manufacturing operations with defined quality requirements.
• Contribute to continuous improvement of quality processes and documentation.
• Act as individual contributor with managerial-level responsibility without people management.

Kenntnisse

QA/QC life sciences

GMP/QMS experience

Batch record review

CMO oversight

CAPA investigations

Change control

QC method development

Data review

Cross-functional comms

Ausbildung

BS in Life Sciences

Jobbeschreibung

Actalent in Lexington, MA is seeking a Quality Assurance Manager to lead QA/QC activities for biologics manufacturing. The role focuses on testing, method development, and maintaining robust quality systems, ensuring GMP compliance and batch disposition across internal and external CMOs.

You will review batch records, investigations, CAPAs, and change controls, collaborate with AD/QC teams, and drive continuous improvement of QC methods and data review practices in a hybrid onsite setting.