Associate Director, Pharmaceutical Quality Systems (PQS)

Fujifilm • Holly Springs, NC

15h • Onsite

About The Position

The Associate Director (AD), Pharmaceutical Quality Systems 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, Pharmaceutical Quality Systems 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, Pharmaceutical Quality Systems 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.

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

Requirements

• 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.
• 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.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior