Senior Director, Program Quality

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 actio