The Associate Director (AD), Program Quality 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 AD, Program Quality 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 AD, Program Quality 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.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

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

Minimum 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
• Ph.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 Requirements 

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

Working & Physical Conditions

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 120 minutes.

Ability to discern audible cues.

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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.

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 (FDBN_PNC@fujifilm.com).