Program Quality Manager (PQM)

Merck & Co.; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Program Quality Manager in Holly Springs to serve as the primary liaison between customers and the project team, ensuring QC objectives and commitments are met across analytical methods and transfer activities.

The role handles 2–4 customer programs on average, leads cross-functional QC activities, and works within GMP environments to deliver timely QC deliverables and maintain high-quality standards.

Qualifications

• Bachelor's in Life Sciences, Chemistry or Engineering or equivalent with 5+ years of applicable industry experience, OR Masters with 3+ years, OR PhD with 0+ years.
• 5+ years of project management experience preferably in biotechnology, Pharma, CRO, or CLO.
• 1-3 years experience in customer relationship management.
• 1-3 years experience in a GMP environment.

Responsibilities

• Act as primary QC contact for external customers and partners for all QC teams involved in customer collaboration.
• Understand and communicate customer quality needs to internal teams, including QC teams.
• Support Sales in drafting Scope of Work related to QC analytical methods and testing.
• Lead meetings between clients and QC transfer leads to ensure high performance of QC activities.
• Represent QC in cross-functional meetings and participate in program kickoffs and status reviews.
• Drive QC project management initiatives related to method transfer and timely delivery of client commitments.
• Organize and facilitate QC project teams with agendas, summaries, and action logs.
• Provide timely responses to clients regarding readiness, deviations, changes, and product disposition.
• Ensure escalation for unresolved QC-related issues and risks.

Skills

GMP knowledge

Quality systems

Analytical thinking

Project management

English fluency

Stakeholder management

Education

Bachelor's in Life Sciences, Chemistry or Engineering

Master's in Life Sciences, Chemistry or Engineering

PhD in Life Sciences, Chemistry or Engineering

Job description

Position Overview

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

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Acts as primary QC contact for external customers and partners for all FUJIFILM Biotechnologies 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 FUJIFILM Biotechnologies, Holly Springs teams and across FUJIFILM Biotechnologies 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.

Knowledge, Skills, and Abilities

• Knowledge of GMP and quality systems.


• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.


• Excellent oral and written communications skills and fluency in English.


• Excellent organizational and critical thinking skills.


• Attention to detail and commitment to maintaining the quality standard.


• Ability to navigate complex stakeholder interactions.


• Commitment to sustainability and innovative solutions.


• Problem solving & conflict resolution.


• Ability to manage multiple assignments while meeting timelines in a GMP environment.


• Understanding of analytical methods and working in a GLP or GMP laboratory.

Minimum Qualifications

• 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 Qualifications

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

Physical Requirements

• Ability to discern audible cues.


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


• Ability to sit for prolonged periods of time for 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.

*LI-Onsite

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]).