Manufacturing GMP Specialist
Quality Assurance
Netherlands, Leiden
Fulltime
V-
Competitive
Are you the Manufacturing GMP Specialist to join the Compliance team within the Biotherapeutics Operations department at our client in Leiden? This role is crucial for maintaining and enhancing our GMP compliance culture amidst growing operational demands. If you have a knack for turning challenges into opportunities and are passionate about improving GMP compliance processes, your skills are in demand.
What You Will Do:
Lead the charge in operational inspection readiness and GMP compliance enhancements.
Serve as a primary advisor on cGMP matters and spearhead GMP training initiatives.
Play a pivotal role in the development, implementation, and oversight of GMP processes, including audits, quality reviews, and risk assessments.
Collaborate closely with operational departments to ensure continuous GMP compliance.
We’re Looking For Someone Who:
Holds a Bachelor’s or Master’s degree in Biotechnology, Biochemistry, Biopharma Process Technology, or a related field.
Brings at least 4 years of experience in GMP or Compliance roles, with a deep understanding of cGMP guidelines such as EudraLex – Volume 4 and ICH Q7, Q9, Q10.
Has excellent communication skills in English (Dutch is a plus) and can inspire and lead a team through change and challenges.
Is certified in quality risk assessment or has a strong background in this area.
Why Join Us?
Be part of a leading biopharmaceutical company that’s making a real difference in the world.
Work in an inspiring environment that encourages innovation and professional growth.
Join a team that values collaboration, integrity, and quality in everything we do.
This full-time position is initially offered for one year, with the possibility of extension. Join us to contribute to our mission of ensuring the highest standards of quality and safety in biotherapeutics.
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