Manager / Sr. Manager, Quality Systems & Compliance

Quality Systems & Compliance (QS&C) Sr. Manager will be responsible for the implementation, maintenance, continuous improvement, effectiveness, and compliance oversight of Adicet’s Quality Management System (QMS).  

The role will serve as the Quality Business Process Owner for multiple quality systems and GxP compliance subject matter expert for the site, as well as mentor/coach junior QA team members and GxP personnel on QMS requirements.  Position will own and manage the electronic Quality Management System (eQMS) as it relates to the configuration, implementation, analysis as well as the on-going maintenance of the eQMS to maintain compliance with regulatory requirements. 

Key responsibilities:

• Lead implementation and maintenance of Adicet’s hybrid (electronic and paper-based) QMS and ensure continuous improvement while keeping current with regulations, guidance documents and industry best practices.
• Serve as the site’s Quality Business Process Owner for QMS processes (e.g. Quality Risk Management, Data Integrity, Change Control.
  • Lead cross-functional teams to ensure alignment, maintenance, effectiveness, and compliance of QMS.
  • Identify and lead improvement opportunities to improve product quality and process effectiveness in the QMS lifecycle.
  • Develop and provide tools and training for successful execution of QMS processes.
  • Mentor and coach junior QA team members and GxP personnel on QMS processes and requirements.
• Lead implementation, administrative and maintenance activities for eQMS. This includes sitewide training, troubleshooting, end-user support and consulting with software vendor(s).
• Provide quality oversight and compliance support to implement and validate electronic systems in accordance with Computer System Validation (CSV) procedures and regulatory requirements.
• Lead audits including preparation, execution, reporting, and follow up to any findings.
• Lead inspections and inspection readiness activities to ensure Adicet Bio maintains compliance with regulatory requirement.
• Provide trend analysis and key performance indicators (KPI) to management.

Qualifications:

• BS preferred or related experience in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science.
• 4-6 years of experience in Quality Assurance/Systems, or related role within the biotech/pharmaceutical and/or cell/gene therapy industries.
• 1-3 years of experience with supervising direct reports.
• Strong knowledge GxP, ICH, GAMP-5, EU and CFR requirements and regulations.
• Experience with implementing phase-appropriate hybrid GxP quality system processes and eQMS such as TrackWise, MasterControl, or Veeva.
• Experience in leading audits and inspection readiness activities.
• Excellent interpersonal, oral/written communication, collaboration and influencing skills.
• Ability to lead cross-functionally across various levels of experience and management