Executive Director, Quality Assurance

Posted 18 Days Ago
Be an Early Applicant
Boston, MA
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead all aspects of GMP quality assurance at Verve, including developing and implementing a quality management system, oversight of GMP production and testing, vendor quality management, and QA laboratory operations. Manage the QA team, establish SOPs and compliance standards, and collaborate with other departments on quality-related issues.
Summary Generated by Built In
The Company

Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.

The Position

Verve is seeking an Executive Director, Quality Assurance to lead all aspects of GMP Quality Assurance at Verve. The role involves continued development, implementation, and maintenance of a comprehensive GxP Quality Management System to support all aspects of drug development and manufacturing from preclinical to phase 1 and beyond.

This individual will be responsible for the vendor quality oversight of GMP production and testing of materials and drug product for clinical stage development at external manufacturing sites (CDMOs) and contract testing labs (CTLs) as well as QA oversight of the Verve GxP QC laboratory.

This is a hybrid role and requires three days in our Boston office. We are considering local candidates at this time.

 

Job Responsibilities

  • Provide leadership and oversight for GxP QA including: 
    • Development and implementation of a phase-appropriate Quality Management System, including SOPs, change control, investigations, CAPA, compliance, document management, training management and validation. 
    • Quality Operations function responsible for disposition of GMP materials and products based on review of batch records, test records, regulatory filings, GMP requirements and other Verve requirements. 
    • Vendor qualifications and external/internal audits and regulatory inspections. 
    • QA support for Verve GxP QC laboratory operations.
  • Manage budget and resources to address strategic needs of QA, including hiring decisions, talent management, and mentoring/development of QA team members.
  • Establish and implement SOPs and phase-appropriate quality-related systems and standards to maintain compliance with FDA, ICH, EU, and other country-specific regulations including GxP practices.
  • Identify and address gaps or areas for improvement in systems, procedures, and quality initiatives.
  • Collaborate with Verve Manufacturing, QC, Process Development and R&D on issues such as review and approval of batch records, certificates of analysis/testing and compliance, in-process and release test methods, specifications, stability protocols/reports, analytical method validations, technical study reports, trending reports, etc.
  • Support review of regulatory filing activities, as needed.
  • Establish and maintain Quality Technical Agreements with CDMOs and CTLs.
  • Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs.
  • Maintain a Quality Risk Management system to identify and mitigate compliance risks.
  • Other responsibilities as assigned.

Qualifications

  • BA/BS in scientific discipline required. Advanced degree preferred.
  • 15+ years demonstrated GMP quality experience in the pharmaceutical/ biopharmaceutical industry.  
  • Experienced with drug development for complex biologics.
  • Experience interacting with CDMOs, QPs, and relevant regulatory authorities.
  • Experience with review of regulatory requirements and filings.  
  • Strong interpersonal and communication skills (written and verbal), team player, with good decision-making ability that is results oriented without compromising quality.
  • Demonstrated project management and organizational skills.
  • Strong aptitude with Microsoft Office applications (Word, Excel, etc.).
  • Ability to travel, as needed.

Don’t check off every box in the requirements listed above?  Please consider applying anyway. We want the best candidates for the job, and those candidates don’t always meet 100% of the qualifications listed. At Verve, we are dedicated to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We look forward to learning more about your unique background.

EEO Statement

Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Recruitment & Staffing Agencies

Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.

Top Skills

Gmp
The Company
Boston, Massachusetts
284 Employees
On-site Workplace
Year Founded: 2018

What We Do

Verve Therapeutics is a clinical-stage biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve’s gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-101, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. In 2023, Verve was recognized as a "Best Places to Work" by the Boston Globe. Verve is headquartered in Boston, Massachusetts

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