Senior Manager, Quality Assurance
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-10-17
Listing for:
Katalyst-Healthcares-
Full Time
position Listed on 2026-10-17
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Engineering -
Pharmaceutical
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
- 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.
- 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.
Position Requirements
10+ Years
work experience
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