Senior Quality Assurance Manager

As our QP, you will be at the forefront of ensuring compliance with the Human Medicines Regulations and Clinical Trial Regulations.

Your responsibilities will include:

• Ensure batches are manufactured and tested according to GMP and in line with applicable CTA/IND and PSF regulations
• Review completed batch records and finalize batch dispositions
• Provide QA leadership and technical expertise across all GMP Operations, including Manufacturing, Tech Transfer, Warehouse, Engineering, Quality Control, Supply Chain, and Operations support
• Identify and escalate quality and compliance risks
• Act as the Quality liaison for external clients on commercial programs
• Ensure complaints, deviations, and significant quality incidents are reviewed and resolved promptly
• Provide quality assurance insights for various projects
• Stay informed on regulatory changes to facilitate smooth integration into company SOPs
• Assist in self-inspections by coaching auditors and reviewing audit outcomes.
• Conduct external audits as needed
• Create and deliver training related to the QMS and other role-specific topics
• Ensure all work adheres to GMP, Data Integrity, and Good Documentation Practices (GDP)
• Ensure timely closure of assigned GMP documentation, including CAPAs, Change Controls, and audit/inspection actions