Vice President/Senior Vice President, Quality

1 month ago

Cambridge, United States Editas Medicine Full time
Job DescriptionJob Description

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking a collaborative, highly motivated, and experienced Quality Leader. This is an important position that will lead a team of Quality professionals across Quality Assurance, Quality Operations, Quality Control, Clinical Quality Assurance, and Quality Compliance to develop and shepherd the overall quality strategy in support of early and late-phase clinical development with future commercial approval in mind. In collaboration with functional leaders across the organization, the ideal candidate will have an enterprise mind-set and the ability to drive risk-based and phase-appropriate decisions based on data in the best interest of the patient.

You will be an active member of the Quality-Technical Operations-Technical Development Leadership Team working to define and drive strategies to meet corporate objectives. We’re looking for someone that understands “phase appropriate”, isn’t afraid to take risk, and will roll-up their sleeves and get a little dirty. If you’re interested in building and leading a team capable of great achievements, this may be for you. Diversity of thoughts, experiences and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.

Key Responsibilities:

  • As the VP/SVP of Quality, you will be responsible for:
  • A leadership role expected to embrace Editas’s core values of Engagement, Teamwork, Drive, Resilience, and Accountability.
  • Drive the strategic development and execution of GxP Quality Management System to support all phases of clinical development and future commercial operations.
  • Promote a culture of quality and continuous improvements with a focus on efficiency.
  • Lead GxP teams across multiple sites managing an efficient and compliant Quality Management System and ensuring an uninterrupted supply of drug product.
  • Ensure company-wide adherence to GMP, GCP, GTP, GLP, GDP regulations using industry guidance and best practice.
  • Provide strong leadership in troubleshooting and complex problem solving.
  • Interacts professionally with company management, internal departments, and third parties to provide effective leadership and guidance.
  • Own the Quality Risk Management, Quality Council, and Management Review programs.
  • Ensures a constant state of Inspection Readiness across the organization and strategic partners.
  • Manage budget and resources in alignment with program timelines and deliverables.
  • Author and review regulatory filings (e.g., IND, IMPD, BLA, MAA).

Requirements

Required Qualifications:

The ideal candidate will possess:

  • Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in Microbiology, Biology, or related sciences field; 20 or more years of cGxP experience preferred; consideration will be given to other relevant experience and education.
  • Experience with cell and/or gene therapy products.
  • Strong knowledge in analytical methodologies and technologies.
  • Strong knowledge of global regulations and guidelines (EU, U.S., Japan).
  • Previous experience with clinical and commercial manufacturing, specifically BLA/MAA filings and subsequent inspections and commercial launch requirements.

Preferred Qualifications:

Additionally, candidates with the following attributes are preferred:

  • A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing biotechnology company.
  • Experienced building teams, for both today and tomorrow, through an investment in coaching and development.
  • Inspiring and credible communicator.
  • Collaborative with partners to advance the Editas mission.
  • A resilient and visionary Quality Leader willing to pave a path.
  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.

Benefits

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.

If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.

Fostering Belonging. Fueling Innovation. Transforming Lives.

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