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Associate Director, Quality Systems
hace 1 mes
Verve Therapeutics is a clinical-stage genetic medicines company dedicated to solving the global health epidemic of cardiovascular disease. Our mission is to transform treatment from chronic management to single-course gene editing medicines. We are seeking an experienced Associate Director, Quality Systems to join our team.
Job Summary:The Associate Director, Quality Systems will be responsible for the 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 collaborate with Quality Operations, Quality Control, Technical Operations, Clinical Operations, and R&D to establish, review, revise, and implement phase-appropriate quality-related systems and standards.
Key Responsibilities:- Develop and implement phase-appropriate Veeva-based Quality Management System to maintain compliance with FDA, ICH, EU, and other country-specific regulations.
- Collaborate with other Verve departments to establish, review, revise, and implement phase-appropriate quality-related systems and standards.
- Implement, manage, and maintain GxP training.
- Support CMC documentation and records management.
- Implement Quality Management Review process and work with Quality Operations to maintain KPIs for product and process quality.
- 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.
- 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.
- 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.).
Verve Therapeutics is a clinical-stage genetic medicines company dedicated to solving the global health epidemic of cardiovascular disease. We are committed to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We are an equal opportunity workplace and 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.
