Pharmaceutical Quality Coordinator (F/M)

Pharmaceutical Quality Coordinator (F/M)

MedinCell® is a fast-growing pharmaceutical company developing innovative long-acting injectable therapies based on its proprietary BEPO® technology.

We are looking for a Pharmaceutical Quality Coordinator to support our pharmaceutical quality activities across the development lifecycle, from lead candidate selection through clinical trials.

Reporting to the Senior Vendors Compliance & CTS Manager, you will help ensure GxP compliance across our external vendors, clinical trial supply activities, internal operations, partners and development projects. You will collaborate closely with Pharmaceutical Development, Clinical, Regulatory, Non-Clinical, Project Management, QHSE, Legal, Alliance Management and other internal teams.

Key Responsibilities

GxP vendors compliance

• Support the management of GxP vendors from selection, qualification to performance monitoring, including raw materials manufacturers, CDMOs, testing laboratories, non-clinical & clinical CROs, clinical trial supply providers and other outsourced vendors.
• Prepare, support and/or conduct vendor initial & follow-up audits until CAPAs closure.
• Contribute to the investigation of vendor-related deviations, changes and complaints.
• Support the quality assessment of API manufacturers, including the review of relevant regulatory documentation as Drug Master File.

Pharmaceutical quality and GxP compliance

• Support Pharmaceutical quality and GxP compliance across internal projects, external vendors and partners including the quality review of documentation for clinical trial applications.
• Draft, review and maintain SOPs, templates and quality documentation linked to Pharmaceutical activities.
• Contribute to internal investigations, change controls, CAPAs related to GxP compliance and continuous improvement initiatives.
• Participate in vendor quality and technical meetings as well as in the vendor documentation review (Batch records, Product Specification File, …) and support the Quality Agreements implementation & maintenance with Vendors.
• Support Partner audits of Medincell, as well as the quality documentation with Partners including Quality Agreements, Product Specification Files.
• Collect and report relevant quality and vendor-compliance KPIs.
• Support the key activities within Pharmaceutical Development Team, including during the Process & Analytical Transfer to CDMO as well as GMP manufacturing and testing.

Internal batches manufacturing for GLP studies

• Support the implementation of the corresponding quality roadmap and associated procedures.
• Review master and executed batch records for internal batches intended for GLP studies and contribute to their release for use.

Clinical trial supply (CTS) and clinical quality support

• Support the selection and management of Clinical Trial Supply vendors.
• Coordinate activities for the secondary packaging, labelling, distribution, importation, returns and resupply of Investigational Medicinal Products.
• Review CTS documentation, help define clinical label information in line with applicable country requirements, and support the availability of the documentation for customs clearance.
• Provide quality support during clinical trials, including for temperature excursions, deviations, and complaints.
• Contribute to some clinical documentation review, provide requested documentation for Trial Master File completion and support the follow-up of investigator-site (audits if required).

Profile

• Master’s degree, PharmD or equivalent qualification in pharmaceutical sciences, ideally with a quality or industrial pharmaceutical focus.
• At least five years of experience in Quality Assurance and/or pharmaceutical compliance within the pharmaceutical or biopharmaceutical industry.
• Good knowledge of GxP requirements, particularly GMP, including requirements applicable to sterile and injectable products.
• Experience in the qualification and auditing of GxP vendors. Auditor experience or qualification would be an advantage.
• Experience in pharmaceutical development or clinical trials would be appreciated. Experience in clinical packaging and distribution would be a plus.
• Fluent English, both written and spoken. French would be an advantage.

Medincell is an equal opportunity employer committed to fostering an inclusive and respectful workplace. We welcome applications from all backgrounds and believe that diversity strengthens our teams and drives innovation.