Senior Program Quality Lead, GMP & Regulatory Liaison

Socket.dev; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Program Quality Manager to lead quality programs from agreement signing through closure. You will serve as the primary client liaison, ensuring programs align with Quality Agreements, regulatory expectations, and GMP standards.

You will coordinate cross-functional teams, manage risks, and drive audits with the PQS group to uphold contract commitments and quality. On-site role with intense collaboration across functions.

Qualifications

• Bachelor’s, master’s, or PhD in Life Sciences or Engineering with 8+ years in the field.
• Experience in customer/agency management and GMP quality assurance.
• Proven ability to manage complex quality programs and audits.

Responsibilities

• Act as primary client liaison for quality programs between the client and FUJIFILM Biotechnologies, Holly Springs.
• Lead planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
• Coordinate inputs after SOW with impacted functions to ensure quality agreement elements are complete and realistic.
• Ensure quality agreements reflect regulatory requirements (FDA, EU, etc.).
• Oversee contract elements of the Quality Agreement and communicate changes.
• Provide SME support for client audits with PQS team members.
• Lead cross-functional program kickoffs with internal and client teams.
• Educate the organization on key elements/deliverables of the Quality Agreement.

Skills

Program quality

Regulatory compliance

GMP knowledge

Stakeholder management

Quality audits

Change management

Risk management

Project coordination

Documentation control

Training & coaching

Education

Bachelor’s in Life Sciences or Engineering

Master’s in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Program Quality Manager to lead quality programs from agreement signing through closure. You will serve as the primary client liaison, ensuring programs align with Quality Agreements, regulatory expectations, and GMP standards.

You will coordinate cross-functional teams, manage risks, and drive audits with the PQS group to uphold contract commitments and quality. On-site role with intense collaboration across functions.