Vice President Quality Assurance Operations

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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 12). 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.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more importantand 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 peoples 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 70000 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: Description

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 youll 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.

Youll 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 influencefrom 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

Bachelors 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;
Masters 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).

EEO Information

Fujifilm is committedto 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 Information

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 ().

Required Experience:

Exec

Position OverviewThe 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 12...