Full-Time

Quality Systems Supervisor

Editas Medicine

Editas Medicine

201-500 employees

Clinical stage genome editing for disease treatment

Biotechnology

Junior, Mid, Senior

Waltham, MA, USA

Required Skills
Quality Assurance (QA)
Requirements
  • B.S., M.S., with 6-8 years of experience or PhD in a scientific discipline with 1+ years of experience as a Quality professional in the biopharmaceutical industry
  • Experience supporting cGMP biologics manufacturing required
  • A working knowledge of cGMP requirements in clinical or commercial biologics required
  • Expertise performing/assessing root cause analysis investigations required
  • Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products required
Responsibilities
  • Support Editas’ clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team
  • Provide Quality oversight of start-up activities for a new facility and equipment as well as process commissioning & qualifications
  • Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations
  • Author, review and/or approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing and QC testing)
  • Support QA on the floor activities including line clearance and QA process touchpoints as required
  • Establish, implement, maintain, improve, monitor and report on quality and compliance systems including management, review, or performance of associated trending
  • Build and manage a small team of Quality Engineers/Specialists
  • Train and mentor other Quality staff
  • Support clinical lot disposition activities as needed
  • Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments
  • Independently review, manage, and/or perform complex investigations in cross-functional areas
  • Exercise good judgment in issue identification, resolving moderate to complex quality issues, and escalations
  • Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMP
  • Plan and execute work independently with management consultation as needed
  • Supports the organization in maintaining inspection readiness
  • Provide QA oversight for product Shipments
  • Assist in internal and external audits as required

Editas Medicine stands out as a leader in the field of genomic medicine, leveraging the potential of CRISPR gene editing technology to develop treatments for serious diseases. The company fosters a vibrant culture, encouraging collaboration and resilience among its team of 'Editors', and is committed to manufacturing and commercializing durable, precision genomic medicines. With a robust pipeline of treatments in development, Editas Medicine is not only repairing broken genes but also shaping the future of medicine.

Company Stage

N/A

Total Funding

$884.6M

Headquarters

Cambridge, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

11%

1 year growth

25%

2 year growth

11%