Associate Director, Program Quality & Compliance

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Associate Director, Program Quality Management to safeguard quality across customer programs from initial discussions to close. You will collaborate with Program Management and site SLTs to define governance, drive risk management, and ensure timely, compliant QA services.

The role requires senior-level coordination with clients and internal teams, with responsibilities spanning governance, audits, continuous improvement, and

Qualifications

• Experience in customer relationship management or alliance management.
• Experience in quality assurance in a GMP environment.
• Experience in developing and implementing regulatory strategies.
• Experience managing projects, programs, or portfolios.

Responsibilities

• Partners with customers to agree the quality standards/governance/responsibilities for programs and approves Quality Agreements and SOWs.
• Manages key product documentation such as process control strategy and product specification.
• Leads, plans, and executes programs in alignment with Quality Agreements.
• Acts as Quality point of contact for the Program Management team.
• Ensures timely and effective communication between the client and site quality teams and stakeholders.
• Designs risk identification and management processes to highlight program risks.
• Drives decisions with SLT and/or global quality.
• Leads client audits in partnership with PQS team members.
• Leads Quality Management Review for customer programs and drives continuous improvement.
• Ensures delivery of product specification files, annual reviews, QA reviews, and end-of-campaign reviews.

Skills

Quality Management

GMP Compliance

Regulatory Affairs

Project Management

Stakeholder Management

Communication Skills

Education

Bachelor's degree in Life Sciences/Engineering

Master's degree in Life Sciences/Engineering

PhD in Life Sciences/Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Associate Director, Program Quality Management to safeguard quality across customer programs from initial discussions to close. You will collaborate with Program Management and site SLTs to define governance, drive risk management, and ensure timely, compliant QA services.

The role requires senior-level coordination with clients and internal teams, with responsibilities spanning governance, audits, continuous improvement, and