The Senior Manager, Quality Assurance is responsible for leading quality assurance operations, developing and maintaining quality management systems, and ensuring compliance with applicable regulatory requirements and industry standards. This role oversees audits, CAPA, risk management, quality control processes, and continuous improvement initiatives while collaborating with manufacturing, engineering, regulatory affairs, and other cross-functional teams. The ideal candidate has strong leadership, analytical, and problem-solving skills, with extensive experience in quality systems, regulatory compliance, and team management to ensure product quality, safety, and operational excellence.
- 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
- Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field; a master's degree is preferred.
- 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