Department/Group: External Quality Drug Product NA Steriles
Job title : Senior Principal Quality Site Manager, Drug Product Contract Manufacturing
The Senior Principal Site Manager will manage the Quality oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMO) located in Greenville, North Carolina. This person will be the Quality “Person-in-the-Plant” and will be a key member of the CMO governance team to support right to operate and quality supply of three critical biologic products, including a product launch.
· Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of Roche products, including a successful product launch
· Establish and monitor CMO Quality and Compliance goals and metrics to drive continuous improvements; proactively drive quality and compliance excellence
· Recommend, implement, and drive strategic objectives and goals of the CMO relationship
· Manage the release of product, including batch record review, investigations, change controls
· Observe end-to end production activities that include 3 filling lines, thawing, compounding, visual inspection, and bulk packaging operations
· Make decisions if issues arise during production
· Partner with the CMO to ensure proper aseptic control during Roche operations
· Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required
· Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks
· Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS); establish Quality continuity
· Manage and participate in regulatory inspections and Genentech compliance audits at the CMO to secure successful inspection outcomes
· Develop and negotiate Quality Agreements with CMOs
· Support regulatory filings for products manufactured at CMOs
· Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees
· Serve as the Quality representative on cross-functional and multi-site teams and gain internal alignment on cross-functional activities and projects
- B.S. or B.A. degree in Life Sciences, Physical Sciences or related scientific discipline is required. Advanced degree (such as MBA) preferred.
- 15 years of experience in the biotechnology or pharmaceutical industry; including 3 – 5 years of hands-on aseptic manufacturing experience
- In-depth experience in development, installation, and management of adherence to state of the art quality systems; including deviation, change control, complaint, training, validation, trending, and documentation systems
- Experience working in a cGMP-regulated environment within the biotechnology and/or pharmaceutical industry . Demonstrated expert knowledge of cGMPs as well as knowledge of FDA/EU regulatory guidelines, validation practices, and other relevant regulatory requirements.
- Demonstrated expert knowledge of aseptic processing and aseptic packaging operations.
- Ability to interpret Quality standards for implementation and review
- Experience with technology transfer of manufacturing process technology.
- Experience managing contract manufacturing or other 3rd party client relationships.
- Demonstrated interpersonal skills to work effectively with and/or manage internal stakeholders, external business partners and contractors, and cross-functional project teams across multiple locations.
- Demonstrated ability to influence quality mindset, strategy, and processes
- Excellent written and oral communication and presentation skills.
- Strong track record of soliciting input and applying sound judgment to make timely, fact-based decisions.
- Demonstrated ability to influence and negotiate solutions with both internal and external partners
- Ability to travel domestically.
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...