Head of Quality Assurance (m/w/d)
Coriolis Pharma, is a globally operating independent service provider for formulation research and development of (bio)pharmaceutical drugs (proteins, peptides, monoclonal antibodies, RNA/DNA, etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals.
As Head of Quality Assurance (m/w/d) you are responsible for the continuous improvement of quality management systems at Coriolis. Your main tasks will be:
- Organization of a Coriolis wide quality management system including disciplinary responsibility for the Coriolis quality assurance unit
- Heading of the GMP QA group and coordination of GRP (Good Research Practice) QM team
- Planning and performance of internal audits for all quality relevant units
- Planning, implementation and follow-up of corrective actions resulting from audits and authority inspections
- Compilation and approval of a yearly QM status report for senior management
- Organization of QM systems for deviations, CAPAs, changes, OOS and complaints according to GMP/GRP regulations
- Securing that QM systems such as equipment qualification programs, supplier qualification and/or method validation programs are in place
- Organization and management of a system for employee training according to GMP/GRP regulations
- Establishment of a good relationship to regulatory authorities and clients, coordination and follow-up of authority inspections and client audits.
- Negotiation, approval and implementation of Quality Assurance Agreements in quality related matters
- Securing the compliance according to client quality arrangements together with relevant internal stake holders (e.g., Head QC, group leaders, project managers)
- Conduction of risk analysis, deviation investigations and changes for QA related topics
- Close collaboration with BD, IT, HR GMP-QC and all operational units with respect to QM related matter
- Approval of GMP-CoA/CoTs
- Master or equivalent University degree in (bio) chemistry, biology, medical sciences or pharmacy, PhD preferred
- Excellent knowledge of GMP and relevant regulations (AMG; AMWHV, Pharm. Eur. USP, JP, ICH, GAMP)
- At least 5 years professional experience and track record in GxP environment of pharmaceutical or biotech companies
- Excellent written and verbal knowledge of English and German
- Very good MS Office skills (Excel, Word, Outlook)
- Very good organizational skills and assertiveness
- Very good communication and leadership skills
- Exact and structured way of working
- Experience in leading people
What we offer you
As a fast-growing company, we offer you the opportunity to take on the exciting tasks and responsibilities as Head of Quality Assurance for our GMP/GRP units. We invite you to design and establish processes and structures and continuously improve our existing QM systems. In an international team, we provide you with competence-based development opportunities. In addition to performance-related remuneration and numerous benefits, we also offer an attractive workplace at the location of Martinsried.
You are reliable, show commitment, want to apply knowledge and learn new things, carry out projects, ensure quality, make a team contribution and work sustainably as well as develop solutions? Then we look forward to receiving your application, including your salary requirements and earliest possible starting date.
Please, visit our website for further informationen: www.coriolis-pharma.com