Senior Director, Program Quality

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Job description

Overview:
The Senior Director of Program Quality (PQ) is responsible for building and sustaining the quality relationship with our partners, through transparent and trusting communications, working with Program Management and site leadership teams to provide unprecedented delivery to our partners.

The incumbent will be accountable for the quality aspects of customer programs from initial discussions through to end of program review/close, working with the customer to define the quality requirements and governance for all programs and agreeing the process control strategy for the program, ensuring the right level of quality at the right time and demonstrating adaptability in ensuring processes meet regulatory requirements and support business aspirations (e.g. KojoX). Leading program specific quality management reviews demonstrating our connection to our Partners and curiosity to improve.

External US:
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important-and we are looking for talented candidates to join us. We're 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 us and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. Here at FUJIFILM Diosynth Biotechnologies, you determine what's possible.

In this role, you will act as the voice of customer quality to the SLT ensuring risks are escalated and actions/decisions made in a timely manner. You can coach/train personnel of non-Quality roles, in the application of GMP Principles including the underlying rationale of those principles. You will build and maintain good working relationships with all functions on site and all levels of management. The Senior Director for PQ will represent the team and activities at SLT and customer meetings/audit, inspection, and other areas where needed. Your decisions will set the quality standards for customer programs. You will identify risks to prioritize activities to reduce or mitigate the risk. You will make decisions and recommendations on how to mitigate risk and when to prioritize activities across the programs. The prioritization is likely to be wider than just the quality group activities and for the whole program and across programs based on customer need and FDB impact.

Main Activities and Responsibilities:

Partner with the customer to agree the quality standards/governance/responsibilities for the program, documented and approved in the Quality Agreement and Statement of Work (SOW) and/or change orders as necessary

Responsible for the key product specific documentation, such as process control strategy, product specification and sample plan approval ensuring the right quality at the right time and in line with the Quality Agreement/SOWs

Own S&OP business quality milestones for programs, provide timely identification and escalation of at-risk milestones using business tools (eg: Gantt charts, trackers, risk assessments, etc) and drive remediation or mitigation with the site(s)

Lead the planning and execution of the programs in alignment with the Quality Agreement, acting as Quality point of contact for the Program Management team, ensuring timely and effective communication between the programs to client and program to site quality and other functions as necessary with appropriate attendance at site tier/customer project/ customer steering meetings

Use of strong risk identification/management processes to highlight risk to programs, allowing solutions to be implemented without affecting the ability to deliver. Share decisions and recommendations with SLT and or global quality.

Lead and coordinate client audits in partnership with the PQS team members

Generate/update of QC SOW and change orders relating to analytical services and stability and ensure metrics on status and management of costs with finance team, ensuring charges/costs consistent and appropriate for phase and pass through to customers necessary costs

Responsible for onboarding of new contract laboratories for customer raw material/product testing (quotes/MSA/CDA/SOW/QUAG) and for annual performance evaluation of CLOs in conjunction with site Quality

Lead Quality Management Review for customer programs ensuring a focus on continuous improvement, identifying trends and risks and agreeing actions with the customer/site

Accountable for ensuring delivery of product specification files, annual product reviews, product quality management review and end of campaign reviews with learning shared through the organization and across programs

Where customers have programs at multiple sites provide global PQM representation responsible for working across sites to deliver the customer Quality governance, work with the Key Account Manager (KAM) organization to ensure regular feedback and input into relevant customer meetings.

Lead the site Customer Quality team in line with the FDB global aspirations and people strategy, using the people fundamentals as a way of life developing engaged and motivated teams of excellent people who are adaptable to change and curious to challenge. Identify potential candidates for succession plans

Provide Quality oversight to the program specific reference material, ensuring requalification's performed and material available for product testing

All other job duties as assigned.

Background Requirements and Education:

Bachelor of Science (B.Sc.) with 17+ years of relevant experience or an equivalent combination of education; or Master of Science (M.Sc.) with 12+ years of experience; or PhD in Science with 10+ years of experience. The relevant experience desired is in a GMP environment, preferably in a Quality function.

12+ years of team management experience preferred.

5+ years working in the CDMO business or demonstrated customer facing experience

Advanced knowledge and experience in key subject areas (Quality, phase requirements, clinical testing, stability etc.).

Advanced knowledge and experience in the key requirements for the CMC sections relating to FDB activities to partner with customers and provide quality oversight.

Experience in electronic systems (Veeva and Trackwise)

Strong ability to identify trends and themes.

Strong analytical thinking capabilities and can interpret and present data.

Experience in customer/client facing environments.

Experience with conflict management and resolutions

Strong ability to anticipate any issue and maneuver through a solution.

Scope and Accountability:

Responsibilities throughout the lifecycle of a customer program. Involved in winning to project close. Working at all levels of the organization including global quality and SLT and across sites where customers are active on more than one site.

Able to coach and train personnel in non-quality roles, in the application of GMP Principles including the underlying rationale of those principles.

Manage costs and ensure budgeting in line with site agreed budgeting process.

Experienced and knowledgeable in key subject areas (Quality, phase requirements, clinical testing, stability etc.).

Lead discussions with customers and site demonstrating knowledge on product/technology and regulatory expectations.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail .

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.

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