Sr. Program Quality Manager

FUJIFILM Holdings America Corporation; Holly Springs (MS); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Sr. Program Quality Manager to oversee quality assurance for biopharmaceutical programs. This role serves as the primary liaison between clients and the quality team, ensuring compliance with regulatory standards and the successful execution of quality agreements. The position offers a unique opportunity to contribute to groundbreaking biopharmaceutical developments, including vaccines and therapies, within a state-of-the-art manufacturing facility. Join a mission-driven team dedicated to making a significant impact on global health by delivering innovative solutions in life sciences.

Qualifications

• 8+ years of industry experience in Quality Assurance and customer relationship management.
• Experience in developing regulatory strategies in a GMP environment.

Responsibilities

• Act as primary Quality liaison between clients and FDBN, managing multiple programs.
• Lead planning and execution of programs in alignment with Quality Agreements.

Skills

Customer Relationship Management

Quality Assurance

Regulatory Strategy Development

Risk Management

Education

Bachelor’s in Life Sciences or Engineering

Master’s in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Job description

Position Overview

The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.

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

1. Acts as Primary Quality liaison and project team member between the client and FDBN.
2. Leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
3. After the Sales Team completes the initial draft Scope of Work (SOW), engages impacted functional areas for inputs to ensure the quality agreement elements are complete and realistic.
4. Ensures that the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agencies.
5. Coordinates and monitors completion of the contract elements of the Quality Agreement.
6. Understands the approach and details of the SOW and communicates to the Project PM any work requested beyond the quality agreement/contract that is covered by change orders.
7. Acts as Subject Matter Expert (SME) and provides strategic support for client audits in partnership with the PQS team members.
8. Participates in cross-functional Program Kickoffs (Internal & Client).
9. Educates the impacted organization about the key elements/deliverables of the Quality Agreement.
10. Represents Quality on the project team & steering committee membership as needed.
11. Organizes, leads, and facilitates Quality project teams (internal and external) and determines meeting cadence for each program.
12. 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.
13. Assigns and tracks specific functional accountabilities.
14. Actively conducts risk management within and across programs. Escalates unresolved issues-risks-decisions to functional leaders and/or tier process as appropriate to ensure that SLT knows the impact and potential intervention needed for resolution of potential Quality issues.
15. Tracks and reports programs quality performance through periodic Management Review.
16. Provides timely responses to clients including but not limited to communications involving deviations, change management, product disposition, and all other quality agreement deliverables.
17. Performs Quality approval of high-level documents, including, process control strategy, product specification, and PPQ protocols/reports.
18. Performs other duties, as assigned.

Minimum Requirements

1. Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR
2. Masters in Life Sciences or Engineering and 6+ years of applicable experience OR
3. PhD in Life Sciences or Engineering and 4+ years of applicable experience.
4. Experience in customer relationship management or alliance management.
5. Experience in quality assurance in a GMP environment.
6. Experience in developing and implementing regulatory strategies.

Preferred Requirements

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

Working & Physical Conditions

1. Ability to discern audible cues.
2. Ability to ascend or descend ladders, scaffolding, ramps, etc.
3. Ability to stand for prolonged periods of time up to 60 minutes.
4. Ability to sit for prolonged periods of time up to 120 minutes.
5. 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.

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 ([e-mail]).