Biotech Program Quality Lead

FUJIFILM Electronic Materials (Europe) N.V.

Holly Springs (NC)

On-site

USD 110,000 - 140,000

Full time

14 days+

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Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Program Quality Manager to oversee programs from Quality Agreement signature to closure, acting as the primary client liaison for Quality. Onsite role supporting 1–3 programs, coordinating with global teams and cross-functional stakeholders.

The role requires 5+ years in life sciences/engineering with GMP quality assurance, plus strong regulatory awareness and project management.

Qualifications

Bachelor’s in Life Sciences or Engineering with 5+ years of applicable industry experience, or Master’s with 3+ years.
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.

Responsibilities

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.
Ensures the quality agreement aligns with regulatory requirements including FDA and EU.
Educates the organization on key elements of the Quality Agreement.
Provides strategic support for client audits in partnership with the PQS team.