Director, Pharmacovigilance Quality

Intellia • Cambridge, MA

16d • $213,000 - $260,400 • Hybrid

About The Position

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together. How You Will Achieve More: Are you a strategic quality leader passionate about patient safety and regulatory excellence? We're seeking an exceptional Director of Pharmacovigilance Quality Assurance to build and lead our global PV quality function during an exciting period of growth. As a key member of our R&D quality leadership team, you'll partner with Pharmacovigilance to embed quality and compliance across all product safety activities—from clinical development through post-marketing surveillance. This isn't just oversight; it's strategic partnership that protects patients, satisfies regulators, and enables business success. You'll establish our risk-based QA oversight program, serve as our company's voice during regulatory inspections, and mentor a team dedicated to world-class pharmacovigilance practices. If you thrive at the intersection of strategic thinking and hands-on quality leadership, this role offers the perfect platform to make a measurable impact on patient well-being.

Requirements

• Education Bachelor's degree in Life Sciences, Pharmacy, Nursing, or Allied Health/Science AND 10-15 years of pharmaceutical industry experience (minimum 7-10 years supporting pharmacovigilance) or Master's degree in a related discipline AND 7+ years of related experience or PhD in a related discipline AND 4+ years of related experience
• Required Experience & Expertise Demonstrated ability to provide QA oversight of PV activities and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, GCP, and SOPs Expert knowledge of current ICH and health authority requirements (FDA, EMA, MHRA, ROW), expectations, and trends in patient safety and pharmacovigilance Proven experience effectively managing regulatory agency inspections and serving as company representative Deep understanding of global GVP regulations (US/MHRA/EU/ROW), Part 11 computer systems, and all types of PV internal and external auditing Strong knowledge of pharmacovigilance processes, risk-based quality systems, and clinical development Comprehensive understanding of clinical research aspects including protocol development, CRF design, trial management, monitoring, vendor management/oversight, data management, statistical analysis, and regulatory submissions Strategic thinking with ability to contribute to company objectives and achieve goals in creative and effective ways Excellent communication skills (verbal, written, and presentation) with ability to interact effectively with people at all levels of the organization and with external collaborators, vendors, and health authority representatives Ability to work in a remote/hybrid environment with strong interpersonal communication skills Hands-on leadership style with ability to deal with ambiguity and provide creative and pragmatic solutions to issues and risks #LI-SV1 #LI-Remote

Responsibilities

• Strategic Leadership & Quality Oversight Build and lead a world-class PV quality function that protects patients and satisfies regulators.
• Ensuring adherence to reporting standards and company policies Develop and implement a global PV QA strategy and risk-based audit program to ensure compliance with FDA, EMA, MHRA, ICH, and other international regulatory requirements Establish and maintain a compliant QA oversight program for PV,
• Serve as the primary Quality Assurance Subject Matter Expert (SME) for Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) as related to safety data Audit & Inspection Management Drive a risk-based approach to creating, maintaining, and executing the annual PV audit program focusing on:
• Incoming safety data from all sources Compliant case processing and reporting Medical review and signal detection Risk management programs and safety-related labeling Schedule, personally conduct, and/or manage quality audits for PV operations, vendors, partners, and commercial safety activities Lead inspection readiness activities and serve as the company representative during regulatory agency inspections and mock audits Oversee and manage internal and external audits of PV vendors, electronic safety systems, and clinical/post-marketing PV documents Quality Systems Management Provide comprehensive QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment Oversee the Quality Management System (QMS) with appropriate metrics, trending analysis, and risk indicators Manage the PV deviation and CAPA program, including investigation and timely closure of issues Author and maintain QA PV Standard Operating Procedures (SOPs) and Work Instructions (WIs) Provide quality oversight for all PV-related documents, ensuring alignment with regulatory requirements Cross-Functional Collaboration Partner with the PV Operational team to problem-solve, strategize, and provide compliance guidance Collaborate with Clinical Development, Regulatory Affairs, Commercial Operations, and other departments to optimize GVP education, training, compliance, and inspection readiness Act as Key Opinion Leader for GVP regulations, process strategies, and regulatory guidance (domestic and international) Assist in vendor selection, qualification, oversight, and risk-based auditing of third parties supporting PV activities Continuous Improvement & Regulatory Intelligence Lead process improvement projects and identify gaps in systems and processes as part of continuous improvement initiatives Stay current with new and revised regulations, industry trends, and health authority expectations Develop and present periodic metrics and risk management reports to company leadership Provide global GVP training when requested

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees