Program Quality Manager (PQM)

Fujifilm • Holly Springs, NC

6d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior