The Position

Verve 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.

Qualifications

• 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.