This is a senior role with QP responsibility within R&D Quality that is responsible for the operational quality support for the clinical supplies business for clinical trials that are in the direct sponsorship of the company. This role serves as the direct Quality Assurance partner with CMA Clinical Trial Supply, with quality oversight of the clinical trial supplies business processes that include among others IMP supply planning, sourcing, packaging, label design and labeling, storage, order fulfillment, distribution, returns, reconciliation, and destruction.
This role reports into the Head Clinical Quality function.
- Ensures that Quality Management System and standards are in place and operationalized as related to IMP release, storage, packaging, distribution, and sampling for clinical trials.
- Performs clinical trial sponsor release of IMP drug product from GMP perspective in alignment with Manager Clinical Operations for clinical green light. In this context ensures that the quality management of investigational medicinal products (IMP) sponsored by the company for use in a clinical trial are in accordance with Good Clinical Practice (GCP), which is at the interface with and complementary to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Serves as the primary R&D Quality point of contact for Clinical Trial Supply governance, serving as the Quality Assurance liaison between the groups producing IMP (Product Development/Manufacturing/Third Party CMO) and CMA designing and executing the clinical study.
- Ensures QA operational support of clinical trial supplies activities including but not limited to deviation management and CAPA follow-up, change management, audit/inspection, document and training management and vendor management.
- Conducts IMP-related audits at vendor and clinical trial sites.
- Holds quality oversight of clinical supplies vendors.
- Ensures that Quality Agreements are in place for clinical supplies relevant key vendors in accordance with company procedures.
- Holds continuous contact with the QP responsible for the release of the clinical drug substance and the QP responsible for release of the final clinical drug product.
- Ensures GMP principles training for CMA.
- Ensures that quality standards are in place for approved non-sponsored trials such as Investigator Initiated Trials (IIT) in case sponsored IMP to be used by the IIT site.
- Must be a certified EU Qualified Person
- Minimum of 7 years’ experience in a pharma/biopharmaceutical industry environment.
- At least 2 years’ experience in a Quality Assurance role with demonstrated knowledge and experience in GMP/GDP principles as related to clinical drug supply and relevant international standards and regulatory requirements/regulations related to clinical development.
- At least 2 years` experience in a QP role
- Knowledge about clinical trial conduct processes.
- Excellent communication, writing and presentation skills in English for effectively interfacing with internal and external organizations, collaborators and customers
- German as 2nd language is a plus
- Demonstrated ability to work independently and in a team environment
Ability to assess complex issues, break down into components and propose viable solutions.