Summary:  The Quality Assurance Program Quality Manager (QA PQM) is responsible for the operational oversight and execution of program quality requirements from the point of Quality Agreement signature through program closure. This role acts as the primary Quality liaison for assigned client programs, ensuring that program deliverables align with contractual commitments, quality standards, and regulatory requirements. Working in close collaboration with cross-functional teams, the Program Quality Manager helps ensure successful program outcomes through detailed coordination, compliance monitoring, and proactive issue resolution.

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. 

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

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

Essential Functions for QA PQM I:

The major responsibilities/essential functions of this position, including significant tasks, responsibilities, projects, etc. in order of importance or impact, include but are not limited to:

• Will handle an average of one (1) or two (2) customer programs of minimal complexity and scope.
• Serve as the primary Quality contact for assigned clients and programs, participating as a core project team member to represent Quality interests throughout the program lifecycle.
• Will assist and facilitate the planning and delivery of program quality activities per approved Quality Agreements, and ensure compliance with FDA, EU, and other relevant regulatory bodies.
• Work with functional areas after initial Scope of Work (SOW) is drafted to ensure all requirements within the quality agreement are achievable, documented, and aligned with business objectives.
• Coordinate and track completion of contract elements within the Quality Agreement, supporting timely and accurate delivery of commitments.
• Communicate with the Project Manager and other stakeholders regarding requests or changes that impact quality requirements, including initiating change control processes if necessary.
• Support and participate in internal and client-facing program kickoff meetings, providing education on key elements and deliverables.
• Assist in organizing and running Quality project team meetings, preparing agendas, distributing meeting notes, and maintaining an action and risk log.
• Assign and follow up on quality-related tasks and accountabilities across the program team.
• Monitor and communicate program quality performance, risks, and issues; escalate unresolved concerns to functional leaders when appropriate.
• Support Quality review and approval of technical documentation such as product specifications and validation protocols.
• Help prepare for and participate in client audits in collaboration with Quality team members.
• Perform other duties as required to support departmental and business objectives.

Additional Essential Functions for QA PQM II

• Will handle two (2) to four (4) customer programs of relatively moderate complexity and scope.
• May assist in training of junior team members.
• Serve as the primary Quality contact for assigned clients and programs, participating as a core project team member to represent Quality interests throughout the program lifecycle.
• Coordinate New Product Introduction (NPI) assessments with stakeholders.
• Perform other duties as required to support departmental and business objectives.

Required Skills & Abilities:

• Collaborative work style and ability to operate effectively within cross-functional teams.
• Strong organizational skills, attention to detail, and ability to manage multiple assignments in a deadline-driven GMP environment.
• Assess unusual circumstances and use sophisticated analytical and problem-solving techniques to identify the cause.
• Excellent verbal and written communication skills in English.
• Deliver timely responses and updates to clients on program quality activities, including deviations, change management, and product disposition.
• Resolve and assess a wide range of issues in creative ways and suggest variations in approach.
• Receives minimal supervision for routine tasks and general directions only for new assignments.
• Familiarity with regulatory standards, including cGMP, FDA, EU, and risk management practices.
• Effectively adapts communication style for different audiences and frequently provides guidance to others on complex issues.
• Enhance and strengthen relationships and networks with senior internal and external partners, even when they are not familiar with the subject matter and may require persuasion.
• Handles problems of varying complexity where analyzing information requires evaluating clearly defined factors.
• Applies evaluation, judgment, and interpretation to determine the most appropriate course of action.
• Works independently, with review occurring at key milestones.
• Develops solutions using limited data and precedents and modifies existing methods to address challenges.
• Proactive problem-solving and conflict resolution skills.
• Ability to work in office and manufacturing areas.
• Ability to navigate complex and evolving program requirements and stakeholder expectations.
• Experience with quality management systems, documentation, and tracking tools.

Working Conditions & Physical Requirements:

• May require prolonged periods of sitting or standing.
• Regular use of hands for computer work and documentation.
• May require lifting up to 10 lbs.
• Must be flexible to support a 24/7 manufacturing operation as needed.

Note: This job description outlines general duties and requirements and may be adjusted based on business needs. The Program Quality Manager (Level I/II) will not have direct or indirect personnel reports but will be responsible for leading program-specific quality activities through coordination and influence.

Basic Qualifications for QA PQM I:

• Bachelors in Life Sciences, Chemistry or Engineering or equivalent with 2+ years of applicable industry experience.
• Prior customer relationship management experience/project management experience.

Basic Qualifications for QA PQM II:

• Bachelors in Life Sciences, Chemistry or Engineering or equivalent with 4+ years of applicable industry experience OR
• Masters in Life Sciences, Chemistry or Engineering and 2+ years of applicable experience OR
• PhD in Life Sciences, Chemistry or Engineering and 1+ years of applicable experience.
• 3+ years of project management experience.
• 2+ years' experience in customer relationship management.

Preferred Qualifications:

• Prior project management experience in industry or related.
• Prior customer relationship experience in industry or related.
• Additional certifications in project management (e.g., PMP) or Quality Management (e.g., Six Sigma, ASQ CQE) are an advantage.
• Training or experience in Quality Risk Management principles.
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).