Quality Control Manager
The responsibilities of the Quality Control Manager are to ensure that the premises and equipment where quality control operations are carried out are appropriate and maintained under suitable conditions and live up to regulatory requirements from MPA, EMA, and FDA. Likewise, the QC Manager is responsible for that the personnel working under his/her responsibility are adequately trained.
The person responsible for quality control supervises all quality control procedures. This person assumes the responsibility for the following tasks:
- Approval of specifications, sampling instructions, test methods and other quality control procedures
- Approval of conditions for outsourced testing
- Control of raw materials, starting materials, packaging materials, intermediate, bulk, and finished products (including approval or rejection thereof)
- Supervision of the control of the reference and/or retention samples of materials and products
- Ensuring that all necessary testing is carried out and the associated records are evaluated.
- Ensuring the monitoring of the stability of the products
- Participation in investigations related to the quality of the product
Additionally, this position will participate in the day-to-day quality control operations to ensure clinical and commercial supply. The candidate will help improve processes for drug product analysis. The position will report to the COO.
Qualifications
- Practical experience of quality control in a regulated environment (pharmaceutical industry or closely related field), at least 3 years
- Working knowledge of GMP, especially applied to quality control processes
- MS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience
- Experience in several analytical techniques, including but not limited to, Flow Cytometry, Real Time qPCR, ELISA, Cell Viability measurement, etc.
- Extensive cell culture experience
- Team management experience and strong collaboration skills at all levels
?Preferred
- PhD degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field
- Excellent oral and written communication skills. Strong technical and scientific writing ability
- Experience in setting up methods and planning projects
- Experience in performing analytical method validation and supporting method transfer activities
- Experience with cell therapy manufacturing
- Experience with QC in bio-pharmaceutical development
- Experience with environmental monitoring of cleanrooms and microbiology
Applicants are evaluated on an ongoing basis.
For further information, contact me on kjetil.nyjordet@medella.life.