Quality Operations Manager
Kelly Scientific Resources is a competent and experienced partner of the life science industry.
On behalf of our client, a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases, we are looking for a
Quality Operations Manager
Major duties and responsibilities:
- Provide quality/compliance subject matter expertise to Supplier Relationship Management, Global Procurement and Supply Chain in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs
- Partner with Quality system manager to develop and maintain the quality system
- Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturers
- Manage the quality metrics programs in relation to Third Party performance
- Ensure that the necessary Quality Agreements are prepared, reviewed and revised to support manufacture and testing of company’s products at TPMs
- Prepare Annual Product reviews as required for end toend product monitoring
- Perform product disposition activities which are aligned to ensure the timely supply of drug substance and drug product that meets clinical and commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings
- Review and approve TPM batch records, validation reports, deviations and change controls and directly interface with TPM QA management regarding any potential compliance gaps, significant deviation resolution and regulatory inspections
- Work with TPMs, vendors and analytical laboratories to evaluate their PAI readiness and work with these groups to ensure that appropriate corrective actions
- Represent company Quality during any regulatory agency inspections of the TPM site and ensure timely responses to any issues which may be identified
- Lead Quality Council meetings with the TPM and provide regular communication and progress reports to management
- Minimum B.S.degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
- Minimum of 8 years of experience in biopharmaceutical operations, with at least 5 years in Quality Assurance desired.
- Prior experience with performing lot disposition is desired
- Candidates with a degree in Microbiology and/or prior experience with microbiology and aseptic operations are highly desirable.
- Ability to assess the right balance between the business implications, technical considerations and quality decisions.
- Strong negotiation, communication and presentation skills across all levels
- Demonstrated technical expertise in resolution of deviations, development of effective CAPA and use of risk assessments.
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met.
Are you ready for a new challenge and open for a temporary position for at least 6 months? Then apply today!
Ms. Tanja Güntert, PhD (Tel: +41 (0) 44 225 41 07) will tell you more about your new position and your new employer.
Kelly Services (Schweiz) AG, Löwenstrasse 29, 8001 Zürich, Opening hours Mo - Fr 8h00 – 12h00 / 13h30 – 18h00