Job Summary (Primary function)
The Senior Manager, Clinical EU Qualified Person, will support the Incyte Netherlands entity, in charge of importation and release of Investigational Medicinal Product (IMP) in the EU/EEA.
Clinical QP will support and maintain the site Quality Management System and will act as Incyte IMP EU QP to perform IMP Product batch certification.
Essential Functions of the Job (Key responsibilities)
• Ensure Incyte Biosciences Distribution Inspection readiness;
• Maintain Incyte Netherlands GMP/GDP regulatory licenses for IMPs;
• Interact with Dutch and European Authorities as it pertains to the Incyte Netherlands Licenses for IMPs;
• Perform regulatory watch for European region, assess impact for Incyte and ensure implementation;
• Support establishment of other European licensed affiliates for IMPs;
• Support Inspection readiness Program at other licensed entities;
• EU/EEA Qualified Person responsibilities:
o Batch release and certification of IMPs in the EU in accordance with EU GMPs Annex 16;
o Act as back-up of Commercial QP for commercial batch release
o Review of regulatory submission documents related to Incyte IMPs.
o Provides QP GMP declarations in support of regulatory fillings;
o QP review and evaluation of deviation, complaints, change controls and quality-related documents;
o Perform External and Internal audits;
o Establish QP to QP agreements when required;
o Represent Incyte Global R&D QA in cross-functional project team meetings;
o Be continuously contactable.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Graduate degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
• At least 7 years of QA experience in the pharmaceutical industry with at least 3 years experience as IMP QP;
• Must have extensive QP experience related to early development IMPs (small molecule and Biologics).
• Eligible to be registered as EU QP in Netherlands
• Thorough knowledge in cGMP and global regulatory requirements (US, EU, CH);
• Qualified Auditor
• Strong problem solving skills;
• Excellent verbal and written communication skills with well-structured communication and presentation ability;
• Results focused which may require pragmatism, negotiating skills, empathy, diplomacy
• Team player and ability to work independently with remote teams
• Dutch and English fluency written and spoken (the company language);
• Experience supporting new operations/projects/systems;
• Travel up to 20%
More Information
- Experience Level Junior
- Total Years Experience 0-5
