The Vice President, Quality Assurance Operations, Early-Phase Manufacturing provides strategic and operational leadership for phase-appropriate GMP quality across internal development/clinical manufacturing and a global network of client programs for investigational products (Phase 1–2). The role ensures patient safety, regulatory compliance, and reliable clinical supply by implementing fit-for-purpose quality systems, overseeing batch disposition, and maintaining inspection readiness for US/EU markets.

The work we do at FUJIFILM 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 Biotechnologies and help make 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. 
 
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

As the principal QA interface for sponsors, the role ensures establishment and adherence with customer/Fujifilm Quality Agreements, establishes due diligence and audit framework across the network, drives transparent oversight of deviations/CAPA, change control, and data integrity across customer programs and critical suppliers. Partnering closely with Business Development, Program Management, PD/MSAT, Manufacturing, Clinical Supply, and Regulatory CMC, this leader enables rapid, compliant tech transfer and on-time delivery of DS/DP/IMP whilst ensuring seamless transfer into late phase manufacturing sites.

Where applicable, the incumbent may serve as QP or oversee QP certification activities for EU IMPs.

The incumbent reports to the Chief Quality Officer and is a member of the senior Global Quality Leadership Team.

What you’ll do

• Set the QA vision, operating model, and governance for early-phase operations in a multi-sponsor CDMO environment; align quality objectives with client milestones and contractual commitments.
• Build and lead a high-performing QA organization; embed a proactive, patient-centric, service-oriented quality culture with clear program governance and quality metrics (RFT, deviation/CAPA cycle time, on-time batch disposition).
• Proactively mitigate risk through exception management, change control, and supplier quality oversight; serve as executive sponsor for FDA/EMA inspections and direct global response strategies and CAPA effectiveness verification.
• Act as the executive quality representative for internal stakeholders and external partners (including regulators and strategic customers); negotiate and govern Quality Agreements with transparency and timely deliverables.
• Architect and evolve a phase-appropriate QMS leveraging digital tools and continuous improvement to reduce NPI lead time and cost; harmonize procedures across sites and implement risk-based validation, documentation, and knowledge management.
• Partner across the enterprise (Quality Leadership Team, Site Heads, PD/MSAT, Manufacturing, Clinical Supply, Regulatory CMC, Program Management, Business Development) to integrate quality into program and portfolio decisions and ensure on-time DS/DP/IMP delivery and readiness for filings (MA/BLA).
• Shape company direction via strategic planning, investment cases, and network-level quality initiatives; standardize best practices across sites.
• Where applicable, serve as QP or oversee QP certification activities for EU IMPs.

Scope and impact

• Global QA oversight of PD/early-phase manufacturing operations, including internal QA operations and batch release.
• Leadership through senior QA leaders and site teams across multiple facilities and geographies; accountability for inspection readiness and batch disposition.
• Stewardship of the early-phase QA operating budget, quality systems investments, and resource allocation; influence on quality provisions in customer contracts that affect margin and risk.
• Decision rights that materially affect patient safety, regulatory outcomes, clinical supply continuity, sponsor satisfaction, and corporate reputation.

You’ll excel if you

• Are a strategic, enterprise-level leader who can translate vision into execution and measurable outcomes.
• Are adept at leading global, multi-site organizations and scaling phase-appropriate QMS, digital workflows, and continuous improvement.
• Communicate with clarity and influence—from the shop floor to regulatory agencies and executive stakeholders.
• Build diverse, high-performing teams, coach senior leaders, and foster a culture of accountability, collaboration, and patient focus.

Minimum Qualification Requirements

• Bachelor’s degree in a scientific discipline (e.g., Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, etc.) with 15+ years of pharmaceutical/biologics manufacturing site quality leadership and a proven track record of working on early phase programs ultimately resulting in commercial manufacturing certification or;
• Master’s degree in a scientific discipline (e.g., Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering) with 10+ years of pharmaceutical/biologics manufacturing site quality leadership and a proven track record of working on early phase programs ultimately resulting in commercial manufacturing certification.
• 10+ years’ experience managing, leading and developing people; +5 years leading senior leaders responsible for functional areas.
• Very solid experience hosting FDA inspections and inspections from EMA authorities.
• Demonstrated success leading global QA teams and multi-site operations; proven track record hosting FDA, EMA, and other authority inspections with positive outcomes.

Preferred Requirements

• PhD or PharmD preferred.
• Qualified Person (QP) eligibility/certification for EU IMPs desirable (or oversight of QP certification activities).

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 (fdbglobaltalent@fujifilm.com).