Quality Program Manager (QA Engineer)

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Quality Program Manager is accountable for programs from the point of initial customer engagement through program closure. The Quality Program Manager ensures FDBN provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). The Quality Program Manager is the primary client liaison representing Quality at FDBN. The Quality Program Manager typically handles an average load of 2-4 programs and receives coaching & guidance from the Associate Director, QA Operations.

What You'll Do

• Leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives)

• Primary Quality liaison and project team member between the client and FDBN

• Engages impacted functional areas for inputs to ensure the Quality Agreement elements are complete and realistic after the Sales Team completes the initial draft Scope of Work (SOW)

• Ensures the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agencies

• Coordinates and monitors completion of the contract elements of the Quality Agreement

• Understands the approach and details of the SOW and communicates to the Project PM of any work requested beyond the Quality Agreement/contract is covered by change orders

• Leads and coordinates client audits in partnership with the PQS team members

• Participates in cross-functional program Kickoffs (Internal & Client)

• Educates the impacted organization about the key elements/deliverables of the Quality Agreement

• Represents Quality on the project team & steering committee membership, as needed

• Organizes, leads, and facilitates Quality project teams including meeting cadence for each program by providing a standard agenda and meeting summaries (discussion points, decisions, action-risk log).

• Implement a project team meeting cadence which enables appropriate internal discussions and client engagement/communication. Assign and track specific functional accountabilities

• Actively conducts risk management within and across programs. Escalates unresolved issues-risks-decisions to functional leaders and/or tier process as appropriate to ensure that SLT knows the impact and potential intervention needed for resolution for potential Quality issues

• Tracks and reports programs quality performance through periodic Management Review

• Provides timely responses to clients including but not limited to communications involving deviations, change management, product disposition and all other quality agreement deliverables

• Attends and actively participates in all Tier meetings provide program updates. Ensures all action items are completed per the committed timing; ensures appropriate escalation occurs for unresolved issues and risks

• Perform other duties as assigned

Minimum Requirements:

• BS/BA in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience

• 3+ years of experience in GMP Quality Assurance and/or similar role

• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility

Preferred Requirements:

• MS in Life Sciences or Engineering and 4+ years of applicable experience

• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software

• Experience working in a contract manufacturing organization

• Training and/or familiarity with Quality Risk Management principles preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to stand for prolonged periods of time up to 30 minutes

• Ability to sit for prolonged periods of time up to 120 minutes

• Ability to conduct work that includes moving objects up to 10 pounds

• Will warm in warm/cold environments

• Will work in small/enclosed spaces

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.