Associate Director, Quality Systems
4 weeks ago
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 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
The PositionVerve is seeking an Associate Director, Quality Systems. 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 Veeva Quality Management System in collaboration with Quality Operations, Quality Control, Technical Operations, Clinical Operations and R&D.
This is a hybrid role and requires 3-days in our Boston office. We are considering local candidates at this time.
Job Responsibilities- Develop and implement phase-appropriate Veeva based Quality Management System, to maintain compliance with FDA, ICH, EU, and other country-specific regulations.
- Responsible for Veeva modules for QMS, Document Management, Training Management including set up, administration, maintenance, enhancement and improvements to the "out of the box" configuration under change control with computer system validation as appropriate.
- Collaborate with other Verve departments to establish, review, revise and implement phase-appropriate quality-related systems and standards including GxP practices including SOPs, Lab Instructions and other quality documentation, as appropriate.
- Implement, manage, and maintain GxP training.
- Support CMC documentation and records management by ensuring a framework for all required documents are accurately and properly completed, including all batch disposition documents including related deviations, stability data, protocols, reports, etc. are uploaded into the cloud-based Quality system.
- Implement Quality Management Review process and work with Quality Operations to maintain KPIs for product and process quality as well as QMS elements pertaining to training, periodic review, investigations, change controls, deviations and CAPAs.
- Maintain audit readiness for responsible area and assist other groups with audit preparation and execution.
- Implement and manage Quality Risk Management program with Technical Operations management.
- Manage budget and resources to address needs of QA, including hiring decisions, talent management, and mentoring/development of QA team members.
- Identify and address gaps or areas for improvement in systems, procedures, and quality initiatives.
- Other responsibilities as assigned.
- BA/BS in scientific discipline with an advanced degree preferred.
- 9+ years demonstrated GMP quality experience in the pharmaceutical/ biopharmaceutical industry.
- Experienced with QMS development for clinical stage biologics.
- People management experience preferred.
- 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 StatementVerve 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 AgenciesVerve 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.
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