Sr. Program Quality Manager

FUJIFILM; Holly Springs (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player seeks a dynamic Sr. Program Quality Manager to oversee quality assurance programs from inception to closure. This pivotal role involves acting as the primary liaison between clients and internal teams, ensuring compliance with quality agreements and regulatory standards. Join a forward-thinking company that is investing significantly in cutting-edge biopharmaceutical manufacturing, where your expertise can lead to the development of life-saving therapies. Be part of a passionate team dedicated to making a real difference in the healthcare landscape, while enjoying a culture that fosters growth and innovation.

Qualifications

• 8+ years of industry experience in quality assurance and customer relationship management.
• Strong background in regulatory strategies and risk management.

Responsibilities

• Act as primary Quality liaison between clients and internal teams.
• Lead planning and execution of programs in alignment with Quality Agreements.
• Monitor and report on programs' quality performance.

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

Tools

GMP Environment

Quality Risk Management Principles

Project Management

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.