Hobson Prior are seeking a Director GMP QA to join a biotechnology company to work remotely across anywhere in Europe. Our client are focused on evolving the treatment of cancer patients with pioneering targeted therapies.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Accountable for the GMP compliance of key CMO activities for their products.
• Manage QA liaison between designated CMO and our client.
• Quality oversight of analytical development and review of analytical methods and results, trending, and investigation.
• Support for regulatory submissions.
• CMO performance monitoring and ensure compliance to the Quality Agreement.
• Product Quality Review (PQR).
• Experience with Process development and Process characterization activities with biological products.
• Review and approve Specifications, Master Batch Records, protocols, reports, including validation, annual review, and other quality documents from the CMOs.
• Review and approve stability testing program and stability studies.
• Perform audits of suppliers.
• Work closely with other cross-functional departments, such as CMC, RA and Clinical.
• Prepare and review quality documents including Quality Agreement, SOPs, deviations, change control, OOSs.
• Confirm manufacturing is performed in compliance with regulatory requirements and commitments.
• Support regulatory inspections of the QMS systems.
• Building and implementation of their Quality policy.
• Management of QA resources for GMP work.
• Participate in regulatory authority inspections (FDA, national, EMA) within GMP, GLP, GCP, GDP and pharmacovigilance.
• Act as a quality advocate ensuring quality build in awareness in processes.
• Contribute in product recalls and resolution of product complaints.

Requirements:

• PhD degree or Master's degree with strong experience in biotech/ biopharma industry.
• At least 12-15 years of GMP QA experience, including comprehensive knowledge of EU and US GMP regulations
• Ability to act as QP advantageous.
• GMP QA experience with biological manufacture is essential.
• Experience with radiopharmaceutical manufacture.
• Experience with commercialisation readiness and launch of products including distribution.
• Experience with Analytical QA.
• Experience with Regulatory Inspections, including PAI.
• Experience working closely with Contract Manufacturing Organisations (CMOs).
• Experience with QMS activities - implementing and managing QMS systems, handling deviations, change controls and OOS.
• Experienced in executing supplier audits and/or internal audits.
• Committed and inspired by the mission of our company to bring safe and effective new therapies to patients.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.