Intellia Therapeutics, Inc. · 19 hours ago
Director, Pharmacovigilance Quality
Cambridge, MA
Full-time
Hybrid
Director/Executive
$213K/yr - $260K/yr
7+ years expIntellia Therapeutics, Inc. is committed to developing curative genome editing treatments for severe diseases. They are seeking a strategic quality leader to build and lead the global pharmacovigilance quality function, ensuring compliance and patient safety throughout product safety activities.
BiotechnologyGeneticsHealth CareMedicalTherapeutics
Responsibilities
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
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
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
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
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
Qualification
Required
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
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
Benefits
Performance-based annual cash bonus
New hire equity grant
Eligibility to be considered for annual equity awards
Company
Intellia Therapeutics, Inc.
Intellia Therapeutics is a leading genome editing company whose mission is to develop potentially curative gene editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
501-1000 employees
H1B Sponsorship
Intellia Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (38)
2023 (63)
2022 (46)
2021 (10)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.54BKey Investors
OrbiMed
2022-11-30Post Ipo Equity· $300M
2021-06-30Post Ipo Equity· $690M
2020-11-30Post Ipo Equity· $201M
Leadership Team
John Leonard
President and Chief Executive Officer, Member Board of Directors
Edward Dulac
Chief Financial Officer
Recent News
2025-12-29
EIN Presswire
2025-11-26
Company data provided by crunchbase