The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Biotechnologies, Morrisville (FDBU) 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 FDBU 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 OverviewAt FUJIFILM Diosynth Biotechnologies U.S.A., we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Diosynth Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
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
Major Accountabilities
Acts as Primary Quality liaison and project team member between the client and FDBULeads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives)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 realisticEnsures that the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agenciesCoordinates and monitors completion of the contract elements of the Quality AgreementUnderstands 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 ordersActs as Subject Matter Expert (SME) and provides strategic support for client audits in partnership with the PQS team membersParticipates in cross-functional Program Kickoffs (Internal & Client)Educates the impacted organization about the key elements/deliverables of the Quality AgreementRepresents Quality on the project team & steering committee membership as neededOrganizes, leads, and facilitates Quality project teams (internal and external) and determines meeting cadence for each programProvides 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/communicationAssigns and tracks specific functional accountabilitiesActively 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 issuesTracks and reports programs quality performance through periodic Management ReviewProvides timely responses to clients including but not limited to communications involving deviations, change management, product disposition, and all other quality agreement deliverablesPerforms Quality approval of high-level documents, including, process control strategy, product specification, and PPQ protocols/reportsPerforms other duties, as assignedKnowledge, Skills, or AbilitiesCollaborative 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 EnglishExcellent organizational and critical thinking skillsAttention to detail and commitment to maintaining the quality standardsStrong understanding of regulatory affairs in biopharmaceutical manufacturingAbility to navigate complex stakeholder interactionsKnowledge of Project Management principlesProactive approach to regulatory intelligence and complianceCommitment to sustainability and innovative solutionsProblem solving & conflict resolutionAbility to manage multiple assignments while meeting timelines in a GMP environmentMust be flexible to support 24/7 manufacturing facilityMinimum Education and Experience Requirements Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience ORMasters in Life Sciences or Engineering and 6+ years of applicable experiencePhD in Life Sciences or Engineering and 4+ years of applicable experience Experience in customer relationship management or alliance management Experience in quality assurance in a GMP environmentExperience in developing and implementing regulatory strategies EEO InformationFujifilm 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 InformationIf 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 (HR_FDBU@fujifilm.com).
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