Clinical Quality Assurance Manager 80 – 100% (MP0123)
- Your responsibilities:
- Ensure that clinical activities are conducted in compliance with ICH GCP, applicable regulatory requirements and the company’s procedures.
- Contribute to the maintenance and continuous development of the Quality System.
- Develop, review and train quality/clinical relevantdocumentation and processes.
- Track, assess and follow-up on non-conformities.
- Participate in the selection of clinical research vendors, coordinate and conduct external audits, follow-up CAPAs.
- Interact closely with the development team and external vendors to provide high level QA services. You will report directly to the AssociateDirector Quality Assurance.
- Prepare and host internal audits and inspections.
- Participate in all administrative tasks of the QA team.
- Maintain the archive for long-term storage of regulated documents.
- Monitor trends and changes with regard to regulations, guidelines, recommendations, and identify areas for improvement.
- Support other departments in quality relevant activities.
- Your profile:
- Minimum 5 years of experience in a clinical qualityfunction.
- In depth knowledge of GCP and a good understanding of the legal and regulatory framework around GXP.
- Academic degree in life sciences.
- Working knowledge of GMP and GLP is considered an advantage.
- High degree of accuracy and attention to detail.
- Excellent organization skills and pragmatic problemsolving capabilities.
- Team orientated, strong service delivery focus.
- Fluent in verbal and written German and English (English is corporate language).
Molecular Partners AG is a thriving and steadily growing clinical-stage biotech company located in Zurich, Switzerland. The development of a broad portfolio of therapeutic product candidates in oncology and ophthalmology based on our proprietary DARPin platform allowed a successful listing of the company on the SIX Swiss Exchange (MOLN). Next to our own proprietary pipeline of drug candidates we have entered into collaborations with international pharmaceutical companies, including Allergan and Janssen. www.molecularpartners.com
At Molecular Partners you’ll find rewarding opportunities, diverse experiences and a strong committed team to innovate and advance modern medicine and improve health. You’ll be part of a well-established, fast growing company where innovative, breakthrough medicines are developed. We offer a competitive remuneration package and opportunities to develop and expand your career.
If this sounds interesting to you, then please submit your motivation and detailed CV before May 12, 2016 via e-mail only to: HR@molecularpartners.com. We look forward to hearing from you!