Director - Qualified Person
Rob Angrave is recruiting for a Director, Commercial Affiliate QA GMP GDP & Qualified Person to join an exciting biopharmaceutical company, with a global presence at their site based in Germany. This position is offered on a permanent basis.
Director, Commercial Affiliate QA(GMP/GDP) and Qualified Person is a strategic role to achieve enhanced Quality and Regulatory (GMP/GDP) Compliance within EU affiliates by developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirements and ensuring adherence to GMP and GDP requirements for the product portfolio within the Supply Chain.
Director, Commercial Affiliate QA GMP GDP & Qualified Person role:
- Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standards and local GMP/GDP related regulatory requirements.
- Manage Affiliate documentation and training records within Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes.
- Ensure appropriate and timely management of non-conformances related to relevant GxP (GMP/GDP): deviations, change controls, internal and external CAPAs, Quality Events.
Key duties will include:
- Monitor quality system performance versus local quality relevant GxP and requirements via use of pertinent quality and compliance metrics and goals.
- Perform batch record reviews and deviation review and approval as a Qualified Person (QP) and perform batch release, if qualified and accepted as such by the local competent authority.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional knowledge in Quality Assurance/Compliance and Auditing.
- Fluent in English and German both written and spoken required; intermediate knowledge of French is a plus.
- Experience: at least 5 years of experience in pharmaceutical industry in QA and PV field including GDP for commercial products and GMP.
- Experience in regulatory inspection management, interactions with health authorities.
- Experience as a QP
- Comprehensive knowledge of GMP/GDP requirements and PV regulations including product complaint and recall management.
- Able to manage and resolve technical and tactical issues according to departmental / company procedures and regulations.
It essential that you have authorisation to work in Germany. Please quote 105406 in all communications.