Position Overview

The Sr. Specialist 2, Quality Control Program Manager (QC PQM) serves as the primary QC liaison between customers and the FDBN project team from the point of contract signature through program closure. This role works with customers and FDBN project teams to align QC objectives and initiatives in contracted commitments with FDBN Analytical Method Capabilities and the FDBN company vision/mission (strategy and compliance). The Sr. Specialist 2, QC PQM ensures the timely completion of QC deliverables for customer programs. The Sr. Specialist 2, QC PQM handles an average load of 2-4 customer programs.

Company Overview

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.

Job Description

What You'll Do

• Acts as primary QC contact for external customers and partners for all FDB QC teams involved in the customer collaboration

• Understands and communicates customer quality needs and requirements to internal teams, including QC teams

• Supports the Sales Team in the initial draft Scope of Work (SOW) related to QC analytical methods and testing and engages impacted QC functional areas for inputs to ensure the analytical method transfer and validation expectations are complete and realistic

• Supports the generation of contracts and amendments to Quality Agreements, Statements of Work, and Master Service Agreements together with the global Commercial Development team and Quality Assurance

• Leads, coordinates, and facilitates meetings between clients and QC tech transfer leads to ensure high performance of QC activities

• Represents QC in cross-functional meetings including but not limited to: Program Kickoffs (Internal & Client), Program Status (Internal and Client), Project Teams, and steering committee membership (as needed)

• Drives/participates in Quality management meetings where relevant Key Performance Indicators are shared

• Drives QC project management initiatives related to tech transfer of analytical methods, external testing with CLOs, and timely delivery of client commitments

• Organizes, leads, and facilitates QC project teams for client programs. Provides a standard agenda and meeting summaries (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

• Creates, organizes, and communicates status of QC projects to clients, QC teams, and leadership using project management tools

• Provides timely responses to clients including but not limited to communications involving operational readiness for analytical capabilities, requests for information, deviations, change management, product disposition, and other QC deliverables

• Attends and participates in appropriate internal meetings to provide QC-related program updates. Ensures all QC-related action items are

completed per the committed timing. Ensures that appropriate escalation occurs for unresolved QC-related issues & risks

• Collaborates cross-functionally with other FDBN teams and across FDB sites and prioritize deliverables

• Adheres to the global quality system and supports handling of tasks in accordance with Statement of Works and Quality Agreement

• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s in Life Sciences, Chemistry or Engineering or equivalent with 5+ years of applicable industry experience OR

• Masters in Life Sciences, Chemistry or Engineering and 3+ years of applicable experience OR

• PhD in Life Sciences, Chemistry or Engineering and 0+ years of applicable experience

• 5+ years of project management experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or

Contract Laboratory Organization (CLO)

• 1-3 years experience in customer relationship management.

• 1-3 years experience in a GMP environment

Preferred Requirements:

• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support

and troubleshooting

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes.

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

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

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

Will work in warm/cold environments

Will work in small and/or enclosed spaces.

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.

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 (FDBN_PNC@fujifilm.com).

Job Locations US-NC-Holly Springs

Posted Date 4 days ago (2/14/2025 4:23 PM)

Requisition ID 2025-33448

Category Quality Assurance

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies