Director, Quality Assurance – Clinical and Nonclinical Development at Prime Medicine

Watertown, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Gene EditingIndustries

Requirements

Hands-on QA experience in gene therapy modalities
Track record of sound judgment, collaborative decision making, and effective partnership with cross-functional teams
Ability to be onsite 2-3 days a week in Watertown, MA

Responsibilities

Define and implement the clinical and nonclinical quality strategy for Prime Medicine, embedding ICH E6(R3) and ICH M3(R2)/OECD principles from first-in-human through pivotal stages
Establish and maintain systems and processes (including SOP development) to improve the quality and compliance of both clinical and nonclinical studies, providing oversight and support to CRO GLP studies and internal non-GLP study activities in both the United States and Rest of World (ROW)
Partner tightly with Nonclinical, Clinical Operations, CMC, and Regulatory teams to make risk-balanced, time-bound decisions that protect subjects and program timelines
Maintain and advance the phase-appropriate Quality Management System (QMS) for GCP, applying proportionality to indication, phase, and patient risk; provide input to and perform reviews of Deviation, CAPA, and Change Management records
Ensure data capture, management and analysis is fit for purpose, including audit trail reviews and software assurance approaches to satisfy 21 CFR Part 11/EU Annex 11 compliance requirements
Support or lead QA audits and inspections of clinical and nonclinical sites, vendors and studies, ensuring appropriate follow-up and CAPA closure; contribute to the authoring, review, and revision of SOPs, templates, and procedural documents related to GLP and GCP activities
Ensure nonclinical study protocols are reviewed and approved on time, and that deviations from approved protocols are properly documented, evaluated, and reported
Implement systems and workflows to ensure that data in study reports are accurate, complete, and traceable through the ELN to raw data and animal subjects where applicable
Confirm that bioanalytical method qualification and validation studies are conducted in accordance with internal SOPs, ICH M10, and other applicable regulatory guidance; review bioanalytical method reports for clarity, traceability, and data integrity

Skills

Quality Assurance

Gene Therapy

Clinical Development

Nonclinical Development

Regulatory Compliance

Data Integrity

Risk-Based Quality

GCP

GLP

Prime Medicine

Gene editing technology for genetic diseases

About Prime Medicine

Prime Medicine focuses on gene editing, specifically using a technology called Prime Editing to make precise changes to DNA. This technology can identify and fix faulty DNA segments, which helps restore normal genetic function. The company aims to cure, halt, or prevent genetic diseases, providing long-term benefits to patients. Prime Medicine targets individuals with genetic disorders, a significant market globally. Unlike many competitors, it emphasizes collaboration with research institutions and pharmaceutical companies to advance its technology and bring it to market through licensing agreements and partnerships. The leadership team has extensive experience in developing innovative medicines, and the company is committed to enhancing its technological capabilities.

Cambridge, MassachusettsHeadquarters

2019Year Founded

$306.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Flexible Work Hours

Risks

Intellectual property disputes may lead to costly legal battles and delays.

The competitive landscape in gene editing is intensifying, challenging Prime Medicine's market position.

Reliance on partnerships exposes Prime Medicine to risks if collaborations don't meet expectations.

Differentiation

Prime Editing offers precise DNA modifications without double-stranded breaks, unlike CRISPR.

Prime Medicine's technology can correct faulty DNA segments, restoring normal genetic function.

The company collaborates with top-tier partners like Bristol Myers Squibb for strategic growth.

Upsides

Prime Medicine secured $244.6M to advance its genetic therapies and pipeline.

The partnership with Bristol Myers Squibb includes potential milestone payments over $3.5 billion.

Growing interest in gene editing for rare diseases boosts investment and collaboration opportunities.

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