Sr. Principal Quality Site Manager DP CMO
Roche - Greenville, NC

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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.

Job Duties/Responsibilities:

· 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

Who you are In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.
  • 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.
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Roche is an Equal Opportunity Employer

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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...