Senior Manager Quality Programme
An exciting opportunity has arisen for a Senior Quality Programme manager to be responsible for the coordination of quality input for the company's programme portfolio. You will work various stages, from early development to commercialization and submission, to provide subject matter expert input on Quality-related topics for the biosimilar product portfolio.
- Quality 'single point of contact' or internal program teams with regard to Quality topics of the relevant product portfolio during new product launch preparation, R&D as well as clinical and commercial manufacturing.
- End to end management of Quality tasks for internal Project Teams.
- Give input and consultancy for project related validation activities and commercial manufacturing activities in alignment with commercial quality.
- Initiate and contribute to trouble shooting, as applicable
- Ensure knowledge sharing within Quality,
- Perform GMP audits (routine and for cause) at CMOs and external partners and co-host such visits internally in Alvoteh together with the relevant quality function.
- Identifies gaps and ensures mitigation by addressing it to the relevant functions
- Lead projects or parts of the projects, or be a team member in special projects
Skills & Qualifications
- University Degree in Biology, Biotechnology, Chemistry, Pharmaceutical Science
- 5-8 years relevant experience in GMP environment of Biotechnological Products
- Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation etc.
- Very good knowledge of typical GMP processes like deviation management, root cause analysis, Change Control and submission documentation mandatory.
- Sound knowledge of regulatory standards in Pharmaceutical Industry and expectation of global regulatory bodies
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.