Program Quality Manager; PQM

The 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 Program Quality Manager handles and/or supports an average load of 1-3 client programs.

• Acts as a Quality liaison and project team member between the client and FUJIFILM Biotechnologies, Holly Springs.
• Supports and/or leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
• Ensures that the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agencies and engages impacted functional areas for inputs to ensure the quality agreement elements are complete and realistic.
• Educates the impacted organization about the key elements/deliverables of the Quality Agreement.
• Acts as Subject Matter Expert (SME) and provides strategic support for client audits in partnership with the PQS team members.
• Supports or hosts client onsite visits and establishes ways of working with Partner QA.
• Participates in cross-functional Program Kickoffs (Internal & Client).
• Represents Quality on the project team.
• Organizes, leads, and facilitates Quality workstream (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 Quality subteam meeting cadence which enables appropriate internal discussions and client engagement/communication.
• Assigns and tracks specific action items with functional accountabilities.
• Analyzes, tracks and reports programs quality performance through periodic Management Reviews with clients.
• Provides timely responses to clients including but not limited to communications involving deviations, change management, product disposition, and all other quality agreement deliverables.
• Works with Sr. Director PQM on client interactions, receives coaching and adjusts in agile manner to ensure success of program(s).
• Supports Quality review/verification of high-level documents, including, process control strategy, product specification, and PPQ protocols/reports.
• Performs other duties, as assigned.

• 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 quality principles and regulatory affairs in biopharmaceutical manufacturing.
• Ability to navigate complex stakeholder interactions.
• Knowledge of Project Management principles.
• Commitment to sustainability and innovative solutions.
• Understanding of escalation pathways, 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 and work across sites with same customers.

• Bachelor's in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience,
  OR;
• Masters in Life Sciences or Engineering and 3+ years of applicable experience,
  OR;
• PhD in Life Sciences or Engineering with no prior experience.
• Experience in customer relationship management or alliance management.
• Experience in quality assurance in a GMP environment.
• Exposure to development and implementation of regulatory strategies.