I am seeking a Senior QA Manager to join a fast-growing clinical-stage biopharmaceutical company that works on cutting-edge science with an international team. They are dedicated to the development of transformative therapies for cancer patients.

You will provide expertise in quality oversight of CMC manufacturing and product batch release for externally produced therapies and collaborate with external manufacturing, facilities, MSAT, Validation, Regulatory, and quality units to ensure compliant manufacture of GMP material.

Please note this is a remote position but requires regular travel to the other sites across Europe.

This role will offer you:

• A remote working position with an extremely generous package
• The chance to travel to other manufacturing sites across Europe and the US (Anticipated travel is approximately 20-25%)
• Exciting opportunity to join an early-stage, growing, and dynamic company
• A yearly budget dedicated to the progression of your career

You will be responsible for:

• Managing raw material suppliers, third-party organizations, and leading material review boards
• Providing quality expertise throughout the manufacturing and release process
• Manage, review, and approve Quality and cGMP documentation including CAPA records, Change Controls, Batch records, Deviations/Investigations, SOPs, complaints
• Drive the development and maintenance of quality management systems
• Lead audits and inspections and resolve compliance failures

You will bring the following:

• You should be based in either Germany, the United Kingdom, the Netherlands, Belgium, or Switzerland
• Strong ability to review and evaluate cGMP and Quality documentation
• A self-starter with the ability to work autonomously
• Solid work experience in a senior QA position within Biopharmaceuticals and cGMP/GMP