Senior Manager, Quality Assurance

• Lead QA oversight of transport validation and primary/secondary packaging validation for drug product and finished packaged product at CMOs to support commercial readiness.
• Serve as QA representative on cross-functional teams, providing guidance on quality and compliance based on current global regulations and industry standards.
• Act as QA SME on deviations, CAPAs, change controls, and documentation revisions.
• Review and approve CMO documentation, including specifications, master and executed batch records, label proofs, and validation documentation.
• Establish and report quality metrics, risks, and compliance challenges to senior management.
• Periodically review and revise GMP SOPs and procedures.
• Support inspection readiness for commercial launch.

Qualifications:

• Bachelor's degree in a scientific or technical discipline.
• 8+ years of pharmaceutical industry experience.
• Demonstrated QA oversight of transport validation and packaging process validation strongly preferred.
• Experience managing quality aspects of validation, packaging, and testing at CMOs.
• Experience with process validation (PPQ), commercial readiness, and domestic/ex-US inspection readiness.
• Solid knowledge of US and global GMP regulations and industry practices.
• Strong collaboration and management skills with the ability to handle multiple priorities on aggressive timelines.