Vice President Quality Assurance Operations

Fujifilm • Morrisville, NC

2d

About The Position

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.
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.

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.

Nice To Haves

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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 501-1,000 employees