Senior Program Quality Manager

The Senior Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Biotechnologies, Holly Springs provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FUJIFILM Biotechnologies, Holly Springs Quality. The Senior Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.

What You’ll Do

• Acts as Primary Quality liaison and project team member between the client and FUJIFILM Biotechnologies, Holly Springs.
• Leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
• After the Sales Team completes the initial draft Scope of Work (SOW), engages impacted functional areas for inputs to ensure the quality agreement elements are complete and realistic.
• Ensures that 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 any work requested beyond the quality agreement/contract that is covered by change orders.
• Acts as Subject Matter Expert (SME) and provides strategic support for 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 (internal and external) and determines meeting cadence for each program.
• Provides a standard agenda and meeting summaries such as discussion points, decisions, action-risk log. Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication.
• Assigns and tracks 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 of 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.
• Performs Quality approval of high-level documents, including, process control strategy, product specification, and PPQ protocols/reports.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Excellent oral and written communications skills and fluency in English.
• Excellent organizational and critical thinking skills.
• Attention to detail and commitment to maintaining the quality standards.
• Strong understanding of regulatory affairs in biopharmaceutical manufacturing.
• Ability to navigate complex stakeholder interactions.
• Knowledge of Project Management principles.
• Proactive approach to regulatory intelligence and compliance.
• Commitment to sustainability and innovative solutions.
• Problem solving & conflict resolution.
• Ability to manage multiple assignments while meeting timelines in a GMP environment.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience;
  
  OR,
• Masters in Life Sciences or Engineering and 6+ years of applicable experience;
  
  OR,
• PhD in Life Sciences or Engineering and 4+ years of applicable experience.
• Experience in customer relationship management or alliance management.
• Experience in quality assurance in a GMP environment.
• Experience in developing and implementing regulatory strategies.