Senior Manager of Analytical Quality Control
2 weeks ago
About the Role
We are seeking an experienced Manager of Quality Control HPLC Scientists to lead a growing team of dedicated professionals in our QC Chemistry department. As the head of this unit, you will be responsible for ensuring the quality and integrity of our analytical testing and method validations, while collaborating closely with our sister unit of Analytical QC Technicians and Lab Support Scientist.
Key Responsibilities
- Lead and develop a team of 10 skilled Scientists in close collaboration with our sister unit and Lab Support Scientist
- Ensure the quality and integrity of analytical testing and method validations
- Collaborate with internal stakeholders and departments across the QC area
- Develop and implement LEAN principles in the service area
- Secure transparency, optimize resource prioritization, and collaborate proactively in the leader group and cross-organizational assignments
About the QC Chemistry Department
QC Chemistry is one of five departments in the QC area, responsible for supporting the production of new biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines. We strive to support our internal stakeholders, customers, and patients by providing guidance and resolving challenges in a collaborative and open-minded approach.
Candidate Profile
- University degree in natural sciences (Master's or Ph.D. in Pharmacy, Biochemistry, Engineering, or equivalent)
- 3+ years of managerial experience from leadership positions
- 5+ years of experience in the pharmaceutical industry in CMC-related areas, e.g., CMC development, manufacturing, or analytical departments
- Solid understanding of GMP regulations, documentation, and traceability, analytical methods for marketed products, stability study establishment and reporting, statistics, OOS resolutions, technical transfer of analytical methods, and experience from interactions with regulatory authorities
- 2+ years of experience with LEAN in a service area
- Proactive and open-minded approach
- Strong collaboration skills and experience from working in cross-functional teams
- Strong proficiency in written and spoken English
How to Apply
- Submit your CV for consideration
- Our recruiters will contact you to discuss your application if we see a potential match
- Assessment stage to evaluate key skills required for the job
Location: Copenhagen Site
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