- Our company develops innovative protein therapeutics for the treatment of genetic disorders.
- As the Company further develops, its legal complexity will be increasing thus requiring strengthening of its legal functions.
- At this moment, the company is composed for further science, technology and new product development and commercial roll-out.
- The company is small (approx. 100 employees, based international) and entrepreneurial.
- The QC Manager must fit in this organizational culture where integrity, entrepreneurship and flexibility are core competencies.
Overall purpose of the job
The QC manager is responsible for the complete QC program used for release of CTM and marketed products under GMP quality system.
Main general duties and responsibilities
- Responsible for the QC release and stability test package including managing validation, verification and/or transfer of test methods.
- Responsible for reference standard, internal controls and critical materials used in QC test methods.
- Identifying new CLO’s for QC testing.
- Rationalize and de-risk QC testing
- Management of quality records (change control, non-conformance, CAPA’s)
- Support regulatory submission
- Prepare and conduct inspections of US and EU authorities
- Set up and control of departmental budget
- Coach employees, preside over departmental meeting
- Hold appraisals, and discuss planning and working assignments with employees
- Co-ordinate activities of employees, review progress and quality of activities and provide a good working environment in the department.
scientific work/thinking level, training in biomedical and pharmaceutical sciences
- 5-10 years of experience in the pharmaceutical industry
- Experience with quality systems (cGLP and/or cGMP) and pharmaceutical guidelines
- Experience with validation, verification and transfer of compendial and product specific methods
- Leadership skills
- Good command of English both written and spoken
- Knowledge of project management
- Commercial sense