Quality Program Manager (QA Engineer)

Fujifilm - Holly Springs, NC

Full-time - Mid Level

Holly Springs, NC

Machinery Manufacturing

About the position

The Quality Program Manager (QA Engineer) is responsible for overseeing quality programs from initial customer engagement to program closure, ensuring alignment with contracted commitments and company vision. This role serves as the primary liaison between clients and the organization, managing multiple programs and ensuring compliance with regulatory requirements.

Responsibilities

• Leads the planning and execution of programs in alignment with Quality Agreements.
• Acts as the primary Quality liaison and project team member between the client and FDBN.
• Engages functional areas to ensure completeness and realism of Quality Agreement elements after the Sales Team drafts the Scope of Work.
• Ensures organization of the quality agreement based on work segments and regulatory requirements.
• Coordinates and monitors completion of contract elements of the Quality Agreement.
• Communicates with the Project PM regarding any work beyond the Quality Agreement covered by change orders.
• Leads and coordinates client audits in partnership with PQS team members.
• Participates in cross-functional program Kickoffs (Internal & Client).
• Educates the organization about key elements and deliverables of the Quality Agreement.
• Represents Quality on project teams and steering committees as needed.
• Organizes and facilitates Quality project teams, providing standard agendas and meeting summaries.
• Implements a project team meeting cadence for internal discussions and client engagement.
• Conducts risk management within and across programs, escalating unresolved issues as necessary.
• Tracks and reports program quality performance through periodic Management Review.
• Provides timely responses to clients regarding deviations, change management, and quality agreement deliverables.
• Attends Tier meetings to provide program updates and ensure action items are completed.

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.

Nice-to-haves

• 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.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling