For one of our Pharma clients in the Rotterdam area we are looking for a QA manager. In this role you will be developing and maintaining the Quality management systems, overseeing the quality aspects of the CMO and develop relations ships with them for a rare disease product. You will be reporting to the Operations and Programme manager.
As a QA manager your main responsibilities are:
- Managing strong relationships with the CMO/CRO to ensure quality and relevant regulatory standards. Including GMP/GDP quality processes and audit activities and overseeing the review of manufacturing documentation;
- Acting as a Responsible Person (RP);
- Providing strategic input for the design of investigational and commercial GMP and GDP QA operations and participates in quality agreement negotiations;
- Ensuring appropriate quality systems are in place to support product release and distribution in a compliant and timely manner, and routinely monitors performance in an effort to optimize turnaround;
- Provides updates to management of issues or trending in testing data from contract organizations
- Generates, reviews and/or approves GMP documents such as master and executed batch records, SOP’s, validation protocols and reports to ensure compliance to procedures and applicable standards.
- Provides Quality Assurance leadership, guidance and direction;
- Ensuring Product Quality Complaints are handled efficiently and effectively;
- Deciding on disposition of returned, rejected, recalled or falsified products in the EU;
- Approving any returns to saleable stock in the EU;
- Supports the preparation, coordination, and management of partner and regulatory agency inspections. During inspection, plays support role as facilitator and communicator;
- Keeps up to date with current regulatory guidelines and regulations;
- Keeps records of any delegated duties;
- Ensure that the pharmaceutical quality of the marketed product is maintained during distribution.
Qualifications for the function as a Quality manager:
- At least 5-8 years’ experience with quality systems in a pharmaceutical environment;
- Fluent in written and spoken English;
- Experienced in implementing and maintaining quality systems on the basis of laws and regulations understanding of cGMP, cGDP and EMA/ FDA-regulatory documents;
- Experience in other GxP areas (clinical, pharmacovigilance) is considered an advantage;
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required;
- Additional attributes include an ability to multitask, be flexible, and to thrive in a fast-paced entrepreneurial environment.
More information about the QA manager? Please contact Leonie Koomen at Leonie@heraklespharma.nl or 06-1051 83 23.