Senior Quality Systems Director

hace 2 semanas


Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

Job Overview

Verve Therapeutics is seeking an experienced Associate Director, Quality Systems to lead the development, implementation, and maintenance of a comprehensive GxP Quality Management System. 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 departments to establish, review, revise, and implement quality-related systems and standards, including SOPs, Lab Instructions, and other quality documentation.

• 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.

• Implement Quality Management Review process and work with Quality Operations to maintain KPIs for product and process quality.

Requirements

• 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, team player, with good decision-making ability that is results-oriented without compromising quality.

• Demonstrated project management and organizational skills.



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