Quality Operations Manager Biologics - 1 year contract
Quality Operations Manager Biologics – 1 year contract
QA expertise for 3 party suppliers EU, Asia and US Bristol ‐ Myers Squibb
is a successful and innovative Global Biopharma company. The Global Capabilities Hub (GCH), based in Switzerland in the area of Zug, was created to bring together global capabilities of key operational and functional areas across the R&D, Global Manufacturing Services and Commercial Operations value chain to support and optimize established products.
As part of the External Manufacturing Global Team, the Quality Operations Manager is responsible for the Quality oversight of our Contract Manufacturers supplying drug product with diverse formulations to the global market. In this newly defined role, you will proactively manage Third party manufacturer relationships from a quality and compliance perspective. In this role you will provide QA expertise to support new projects, technical transfers, supplier selection programs, investigations and validation programs. As Quality Manager, you will manage quality events, change control and market complaints programs within your supplier portfolio. In addition, the role provides quality support to Global functional groups such as Regulatory/CMC and local country-based RA Managers and act as Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams. Your Profile:
- BSc in Microbiology, Biochemistry, Pharmacy, or Biological Sciences
- +5 years QA experience in biopharmaceutical Operations
- Hands-on QA experience in commercial manufacturing of Steriles
- Ability to balance quality decisions, business implications and technical considerations
You are ready to face 25% travel requirement (EU and Asia). Experience in biologic drug substance and drug product as well as packaging is an asset. A key success factor will be your ability to build relationships, partnerships and to influence or enforce quality decisions at suppliers. Exceptional negotiation skills, excellent English communication and presentation skills are a key requirement for this role in order to develop strong business partnerships with both internal and external stakeholders. In addition, superb analytical skills are required in order to assess business targets and high scientific quality decisions. This role will provide Subject Matter Expertise in Compliance to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Technology Teams and and will support new projects, technical transfers programs, supplier selection programs, investigation and validation programs.
Step into a highly respected and major leadership role in a fast-moving global environment. Working place is the region Zug in Switzerland.
Interested? Our recruiting partner is looking forward to get in touch with you.
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