As QA Manager you will be responsible for the products for the EU market for our client. Because you will manage the quality aspects at external Contract Manufacturing Organisation, you have to ensure that the operational business is in compliance with Current Good Manufacturing Practice. And always with the focus on the Quality Assurance Agreement, regulatory requirements and the standards from our client.
ResponsibilitiesYour responsibilities as an QA Manager responsible for CMO:
As QA Manager responsible for Contract Manufacturing Organisation for the products for the EU market for our client, you need to have a thorough knowledge of Current Good Manufacturing Practice requirement because you need to ensure that the operational business is in compliance with Current Good Manufacturing Practice. The only way is to have a strong understanding of regulatory requirements for commercial products and a strong understanding of risk assessment and risk management fundamentals/tools.
RequirementsOur client is searching for someone who has: - An BSc., MSc., PhD or higher in Pharmacy, Biology, Microbiology or another related science. - Six or more years" experience in the pharmaceutical industry, with direct experience with Pharmaceutical, Bio-pharmaceutical or API products. - Experience in Quality Assurance Operations, production, Quality Control and/or other relevant operational areas. - Strong Technical understanding of (bio) pharmaceutical processes. - Minimally 5 years in Quality Assurance, and 3 years of management and or project management experience. - Fluent in speaking / writing in English. - Proven track record with Health Authorities.
Other informationOur client is looking for someone who is a team and consensus builder, with definitive and authoritative decision making ability. He or she had the ability to effectively manage multiple, complex priorities. Having experience in combination products is a plus, having experience as QP is an asset. The salary is negotiable for the seniority of the position and it also includes an attractive bonus, pension plan and much more attractive secondary benefits!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.