Quality Program Lead: Client Liaison & GMP Excellence

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs seeks a Program Quality Manager to drive quality programs from contract signature to closure, ensuring alignment with client commitments and company strategy.

The role acts as the primary client liaison for Quality, managing 1–3 programs, guiding quality agreements, coordinating regulatory inputs, and supporting audits and client visits in a GMP environment.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience.
• Master’s degree in Life Sciences or Engineering with 3+ years of applicable experience.
• PhD in Life Sciences or Engineering with no prior experience.

Responsibilities

• Acts as Quality liaison and project team member between the client and FUJIFILM Biotechnologies, Holly Springs.
• Supports and/or leads planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
• Ensures quality agreements are organized by work segments and regulatory requirements including FDA, EU, and other agencies, with input from impacted functions.
• Educates the organization about key elements/deliverables of the Quality Agreement.
• Provides strategic support for client audits in partnership with the PQS team.
• Supports 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 and leads Quality workstreams and sets meeting cadence per program.
• Provides standard agendas and meeting summaries, and implements a Quality subteam cadence for internal and client discussions.

Skills

Collaboration

Written and spoken English

Attention to detail

Quality principles

Regulatory affairs

Project management

Sustainability

Escalation handling

Multitasking

Flexibility for 24/7 operations

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 seeks a Program Quality Manager to drive quality programs from contract signature to closure, ensuring alignment with client commitments and company strategy.

The role acts as the primary client liaison for Quality, managing 1–3 programs, guiding quality agreements, coordinating regulatory inputs, and supporting audits and client visits in a GMP environment.