GVP Vendor Quality Management

Intellia Therapeutics, Inc.•Cambridge, MA

About The Position

As Director Clinical Development Vendor Quality & Governance, you will serve as the lead strategic expert for global oversight of GCP, GLP, and GVP vendors. In this high-impact individual contributor role, you will architect the Clinical Quality Governance framework and ensure all external partners maintain rigorous compliance standards. You will act as the primary liaison for regulatory bodies like the FDA and EMA, leading Inspection Readiness for vendor related topics. Operating with full autonomy, you will transform complex audit metrics into systemic risk mitigation strategies to safeguard the company’s clinical integrity and strategic interests.

Requirements

Ability to navigate complex organizational structures and influence senior stakeholders and external partners without formal hierarchical authority.
Advanced capability to identify, prioritize, and mitigate systemic GxP risks using data-driven frameworks and risk-based decision-making.
Deep interpretive knowledge of global FDA, EMA, and ICH guidelines, with the ability to translate complex regulations into actionable corporate standards.
Proficiency in distilling intricate quality issues into high-level briefings and presentations for the C-suite and Board of Directors.
Expert skills in negotiating Quality Agreements and resolving high-stakes disputes with strategic vendors while maintaining productive partnerships.
Ability to design and oversee sophisticated Key Quality Indicators (KQIs) and metrics programs that drive global continuous improvement.
A high degree of self-direction and the ability to manage a broad portfolio of global responsibilities independently.
Proficiency in managing global audit budgets, forecasting resource needs, and monitoring expenditures for multi-site Clinical Development activities.
Experience working with CROs, vendors, and relationship management.
Demonstrated strategic planning and execution skills required.
Proven ability to design/evolve and /or implement Quality Management Systems in a fit-for-purpose manner enabling effectiveness, flexibility, and adaptability in a dynamic and evolving business model.
Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment.
Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
Minimum of 10–12+ years of experience within the pharmaceutical, biotechnology, or CRO industry, with a deep focus on GCP, GLP, and GVP quality assurance
A Bachelor’s degree in a scientific discipline is required; an advanced degree (M.S., Ph.D., or MBA) is highly preferred.
Proven track record of operating at a Director level as a high-impact individual contributor, demonstrating the ability to drive global initiatives and influence executive decision-making without direct reports.
Strong knowledge of GCP and GMP vendor quality processes.
Extensive experience supporting GCP/GVP and GLP Inspection Readiness and serving as a primary point of contact during major regulatory inspections from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for vendor related matters.
Mastery of risk-based auditing methodologies and the ability to manage complex, multi-year vendor quality agreements and global audit schedules.
Expert ability to synthesize complex data into Key Quality Indicators (KQIs) and trend reports that inform senior management of systemic risks and operational health.
Exceptional interpersonal and negotiation skills, with the professional presence required to represent the Quality organization in high-stakes vendor committees and executive meetings.
Prolonged periods of sitting at a desk and working on a computer.

Nice To Haves

Professional certifications such as RQAP-GCP (Society of Quality Assurance) are a significant advantage.

Responsibilities

Establish and steer the Clinical Quality Governance strategy
Serve as the authoritative Quality representative on global vendor management committees, aligning quality objectives with corporate goals and long-term business needs.
Develop and manage the annual global budget for vendor audits and strategic consultant engagements, ensuring optimal resource allocation.
Drive high-level quality-to-quality partnerships with key vendors, fostering strategic alliances that enhance performance and innovation.
Direct the GxP vendor lifecycle strategy, from qualification and risk-based selection to the maintenance of the Approved Vendor Listing (AVL) using sophisticated risk assessment frameworks.
Oversee the global GxP vendor audit program, ensuring the strategic planning, execution, and reporting of audits are met with the highest standards of integrity and excellence.
Lead the negotiation and implementation of Quality Agreements, establishing standards of accountability for all preferred global suppliers.
Synthesize complex audit metrics and Key Quality Indicators (KQIs) into actionable insights for senior leadership, driving systemic risk mitigation and global process improvements.
Architect cross-GxP mitigation strategies to address complex vendor-related issues, ensuring seamless remediation across internal and external operations.
Accountable for the integrity of the CAPA program, ensuring that root causes are addressed and corrective actions drive permanent effectiveness.
Lead the corporate strategy for Inspection Readiness, serving as the primary point of contact and lead spokesperson during regulatory inspections (e.g., FDA, EMA) involving vendor compliance.
Direct or support investigations into critical quality issues, scientific misconduct, or serious breaches (vendor related), providing senior management with strategic solutions and long-term resolution plans
Provide executive-level guidance on quality expectations and GxP standards to internal and external stakeholders, influencing the global compliance culture.