About this role
About the Role In your role you will act as the primary contact for all quality topics at contract manufacturing organizations (CMOs). You will manage the quality oversight at CMOs and ensure DS quality standards (GMP/GDP) and regulatory requirements are met at external manufacturers for our oncology products, while supporting other DS functions as a quality expert. What You'll Do
- Manage quality oversight at CMOs, handling change control, deviations and/or complaints related to DS products at CMOs
- Define effective CAPAs with CMOs and track timely implementation
- Independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs as DS QA
- Prepare and negotiate QAAs with CMOs and ensure compliance with DS QAAs
- Involve in establishment of new manufacturing processes and site transfer activities; support PPQ and validation activities
- Support CMOs during Authority Inspections and perform DS audits at suppliers as needed
- Identify quality risks at CMOs and escalate issues when necessary
- Act as global information distributor; support global teams to identify quality needs for CMOs
- Share quality-related information from CMOs to global stakeholders within the QA environment and in department meetings
- Participate in the further development of the corporate QM-System
- In global teams act as SME to improve the DS quality system and SOP landscape
- Share knowledge within QA or to other functions to improve CMO management at DS
- Work globally with Supply Chain, CMC, regulatory and others to ensure supply of high-quality products What We're Looking For
- University/FH/Master degree in natural or pharmaceutical sciences (Biotechnology, Bioengineering, Biochemistry or equivalent preferred)
- At least five years of relevant pharmaceutical industry experience including at least two years in QA/QM (Shop Floor QA activities or QA Oversight for Manufacturing) and at least two years in a GxP environment in monoclonal antibody manufacturing
- Excellent knowledge of international GMP/GDP regulations
- Assertiveness, strong communication skills and diplomatic attitude during negotiations
- Team player with high quality consciousness and a solution-oriented mindset
- Very good written and verbal English and German communication
- Experience with managing CMOs or external suppliers is beneficial
- Project management skills is a plus
- Willingness to travel up to 10% domestically and internationally Nice to Have
- Experience with managing CMOs or external suppliers is beneficial Compensation & Benefits
- Not disclosed in the posting.