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Quality Validation – Senior Manager
Responsibilities
- 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