What are the responsibilities and job description for the Director, Quality Control position at Verve Therapeutics, Inc.?
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 a Director, Quality Control to supervise the operation and routine testing of a new in-house Quality Control laboratory for the release and stability of GMP drug substance and drug products. This role involves working on complex problems across functional areas, interacting with key stakeholders to influence corporate objectives, and leading strategic initiatives that align with the organization's mission and values. The Director will be accountable for budgets, decision-making processes, and developing future leaders within the organization.
Job Responsibilities
- Provide leadership to the QC Internal team, including hiring, mentoring, development planning and career progression
- Ensure QC laboratory operations support business and manufacturing schedules.
- Scheduling to ensure projects are adequately staffed and meet deadlines
- Establish and maintain fully effective laboratory systems to ensure integrity of all laboratory results.
- Ensure tracking and trending are completed and evaluated for QC functions.
- Ensure adherence to safety regulations and requirements.
- Perform periodic internal QC system reviews and audits, as well as participate in preparing for and representing QC in regulatory inspections.
- Collaborate with various teams including quality control, analytical development, product development, external manufacturing, supply chain and program management to facilitate cross-functional success.
- Provide technical support, facilitate major OOS, OOT, investigations, deviations, change controls and CAPAs.
- Drive compliance and quality by supporting method validations, instrument qualifications and data integrity.
- Lead high-priority projects to successful completion, ensuring they're on time, on budget, and aligned with business goals. Maximize productivity by strategically allocating resources and keeping objectives front and center.
- Keep operations running smoothly, identifying opportunities for improvement and implementing best practices that drive efficiency, quality, and continuous growth across teams.
- Lead change initiatives with confidence, ensuring smooth transitions and minimal disruption while driving transformation and sustainable growth.
- Take on complex challenges with a proactive approach, turning ambiguous tasks into clear, actionable plans that drive progress and achieve results.
- Other duties as assigned.
Qualifications
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.
