Senior Director, Manufacturing Quality - 2398

Editas Medicine

Editas Medicine

Sales & Business Development, Quality Assurance
Devens, MA, USA
Posted on Monday, July 31, 2023

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Editas is seeking a collaborative, highly motivated, and experienced Quality Leader. This is an important position that will lead Quality Operations for internally manufactured materials at our clinical manufacturing facility in Waltham, MA and our clinical/commercial manufacturing facility being built in Devens, MA. This role will lead Quality Assurance Operations, Quality Control Operations, and Site Quality Systems. In addition, you will partner with Corporate Quality (Quality Assurance, Quality Control, Validation and Quality Compliance) to ensure quality systems are aligned with Editas business strategy, industry standards and global regulatory expectations. This role will ensure the GMP manufacturing facility maintains a state of continuous inspection readiness and will participate directly in Health Authority inspections. You will actively participate with cross-functional teams and activities to ensure completion of objectives while adhering to budget, scope, and schedule requirements.

Key Responsibilities & Accountabilities:

  • A leadership role expected to embrace Editas’s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
  • Lead a team of Quality professionals responsible for the GMP testing and disposition of drug substance and drug product per approved clinical schedules.
  • Provides strong QA oversight of site validation activities (e.g., equipment, facilities, technology transfers, change controls, CSV) in collaboration with Corporate QA.
  • Leads the site Quality Systems team in efficiently managing the Quality Management System (e.g., deviation, CAPA, metrics, change control, document control) in accordance with corporate policy and industry standards.
  • Participate in the design, build and qualification of commercial GMP operations, including GMP QC laboratories, ISO certified clean rooms, and warehousing.
  • Provides direction and leadership at the manufacturing facilities, establishing realistic goals and objectives that are accomplished efficiently, completely and within established timeframes.
  • Interacts professionally with company management, internal departments, third parties and other sites to provide effective leadership and guidance. Partners with peers in manufacturing, engineering, validation, logistics, Corporate QA, and Corporate QC to ensure adherence the QMS and effective issue resolution.
  • Supports the development and implementation the Quality Management System with an eye toward phase-appropriateness and risk management.
  • Responsible for inspection and audit readiness activities of the commercial manufacturing facility in coordination with Corporate Quality. Host inspections and audits and responsible for responses, ensuring timely and thorough follow-up to completion.
  • Member of the Corporate Quality Council with the goal of informing Management Review to Executive Leadership Team.
  • Budget and resourcing responsibilities for Manufacturing Quality with dotted line to Corporate Quality, assuring a holistic view of Quality.

Education & Relevant Work Experience:

  • Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in Microbiology, Biology, or related sciences field; 15+ or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.

.Physical & Travel Requirements (if applicable):

  • Ability to routinely be on site at both the Waltham, MA clinical manufacturing facility and the Devens, MA commercial manufacturing facility.
  • Ability to be present in Cambridge, MA at the corporate headquarters as necessary.

Benefits Summary:

Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.