Associate Director, Program Quality Management

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Associate Director, Program Quality Management to lead quality governance for customer programs and align with site quality teams. You will drive governance, risk management, audits, and continuous improvement across multi-site programs reporting to senior executives.

The role requires deep GMP quality expertise, strategic collaboration with customers, and strong leadership to ensure timely delivery of high-quality biopharmaceutical

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

• Agree quality standards/governance for programs and approve Quality Agreements and SOWs.
• Manage program documentation, such as process control strategy and product specs, ensuring timely quality.
• Lead, plan, and execute programs in alignment with Quality Agreements.
• Act as Quality point of contact for the Program Management team.
• Ensure timely communication between client and site quality teams and attend key meetings.
• Design risk management processes to identify and mitigate program risks.
• Drive decisions with SLT and/or global quality.
• Lead client audits with PQS team and provide strategic quality support.
• Lead Quality Management Reviews focused on continuous improvement and actions with customers.
• Ensure delivery of product specs, annual reviews, and end-of-campaign learnings.
• Provide PQM representation to multi-site customer programs and regional governance.
• Partner with Key Account Manager to feed back into customer meetings.
• Organize and facilitate quality project teams and establish cadence and summaries.
• Assign and track QA/QC responsibilities for stability studies and reference material.
• Perform other duties as assigned.

Skills

Collaboration

Communication skills

Organizational skills

Critical thinking

Regulatory affairs knowledge

Stakeholder management

Regulatory intelligence

Sustainability mindset

Multi-tasking in GMP

Leadership and coaching

Flexibility for 24/7 operations

Education

Bachelor's in Life Sciences/Engineering

Master's in Life Sciences/Engineering

PhD in Life Sciences/Engineering

Job description

The Associate Director (AD), Program Quality Management is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The Associate Director, Program Quality Management works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support business aspirations (e.g. KojoX). The Associate Director, Program Quality Management works effectively, independently and within a team framework, across all business areas, levels of the organization, and with clients to deliver high quality and ensures timely delivery of QA services. This role operates on both a strategic level with senior executives and facilitates operational elements in actual program execution.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Partners with customers to agree the quality standards/governance/responsibilities for programs, documents and approves Quality Agreements and Statements of Work (SOW) and/or change orders, as necessary.
• Manages key product specific documentation, such as process control strategy, product specification and sample plan approvals ensuring the right quality at the right time and aligns the Quality Agreement/SOWs.
• 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 program client and site quality teams, stakeholders, and applicable functions as necessary with appropriate attendance at site tier/customer project/ customer steering meetings.
• Designs strong risk identification and management processes to highlight risk to programs, allowing solutions to be implemented without affecting the ability to deliver.
• Drives decisions and recommendations with SLT and/or global quality.
• Leads and coordinates client audits in partnership with the PQS team members providing strategic quality support.
• Leads Quality Management Review for customer programs ensuring a focus on continuous improvement, identifying trends and risks and agreeing actions with the customer/site.
• Ensures delivery of product specification files, annual product reviews, product quality management review and end of campaign reviews. Shares learnings through the organization and across programs.
• Provides global PQM representation to customers with programs at multiple sites by working across sites to deliver customer Quality governance.
• Partners with the Key Account Manager (KAM) organization to ensure regular feedback and input into relevant customer meetings.
• Organizes, leads, and facilitates Quality project teams (internal and external) and determines meeting cadence for each program.
• Provides a standard agenda and meeting summaries such as discussion points, decisions, action-risk log. Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication.
• Assigns and tracks specific functional accountabilities within QA and QC such as product-specific stability studies and oversight to the program specific reference material, ensuring requalification’s performed and material available for product testing if applicable.
• Performs other duties, as assigned.

Knowledge, Skills, And Abilities

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Strong verbal and written communication skills with ability to effectively present information to others.
• Excellent organizational and critical thinking skills; problem solving & conflict resolution skills.
• Attention to detail and commitment to maintaining the quality standards.
• Strong understanding of regulatory affairs in biopharmaceutical manufacturing.
• Ability to navigate complex stakeholder interactions.
• Proactive approach to regulatory intelligence and compliance.
• Commitment to sustainability and innovative solutions.
• Ability to manage multiple assignments while meeting timelines in a GMP environment.
• Ability to coach, lead, and develop individual contributors.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Engineering or related science degree and 11+ years’ experience in; OR,
• Master’s degree in Life Sciences, Engineering or related science degree with 9+ years of experience; OR,
• D. in in Life Sciences, Engineering or related science degree with 7+ years of experience.
• 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.

Preferred Qualifications

• Training and/or familiarity with Quality Risk Management principles Project management training.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct work that includes moving objects up to 10 pounds.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).