Manager or Senior Manager, Quality Systems and Compliance
Cambridge, MA /
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
Primary contact and administrator of Quality Systems inclusive Document and Learning Management, Compliance, and Metrics.
- System Owner for ELN, Purchasing, Training and EHS across multiple sites
- System Owner for prospective Document, Learning and Quality Management Systems and serve as designated trainer
- Process Owner for SOPs including fostering development, implementation, associated training, and periodic reviews.
- Administer Supplier Quality and Monitoring functions to include assessment/audit management, quality agreement implementation and associated metrics
- Perform and participate in regulatory filing reviews inclusive of data audits, section collation, and formatting pre-publishing.
- Assist with regulatory inspection readiness across sites.
- Track and trend quality system data inclusive of change controls, corrective and preventive actions, audit findings, deviations, complaint information and management notifications.
- Provide QA support for change controls, investigations, CAPA’s and effectiveness checks.
- Lead meetings as necessary and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
- Lead compliance walkthroughs of the site and help to drive the closure of any observations.
- Responsible for identifying risks and communicating gaps for process/systems.
- Participate in continuous improvement of department processes and ensuring the team continues to meet expanding business needs.
- Bachelor of Science in associated discipline
- 10+ years of experience in (bio)pharmaceuticals with Contract Organization and/or Sponsor company
- System administrator / owner for learning and document management
- Attention to detail and good communication skills necessary
- Experience in gap assessments, system implementation, and continuous improvements
- Experienced in GLP/GMP settings
- Advanced Degree (MA/MS/MBA/PhD/PharmD)
- Gene/Cell Therapy (AAV, Gene Editing) experience or expertise helpful
- Experience in a start-up or small company environment a plus!