Sr. QA Specialist, Quality Systems

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.

Key Responsibilities & Accountabilities:

• Oversee deviation/ complaints/ change control/CAPA triage meetings to ensure on-time cross-functional support.
• Supports the compilation, analysis and reporting of metrics, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• Provide onboarding training on quality management systems to facilitate seamless integration for new team members, drive continuous improvement, and promote a Quality Culture.
• Perform QA review and approval for quality records (change control, CAPA, deviation, complaint, EC).
• Author and approve standard operating procedures to support improvement and periodic review.
• Participate in validation activities for enhancements of electronic Quality Management System and electronic Documentation Management System.
• Provides support to the organization to facilitate and implement new quality systems introductions and/or improvements.
• Build and manage metrics dashboards to support real-time record tracking, monthly quality health index, and quarterly quality management review.
• Assist in the planning and facilitating of internal audits.
• Supports audit/inspection readiness of the organization.

Requirements

Knowledge, Skills & Capabilities:

• Proven ability to work independently
• Knowledge, Skills & Capabilities:
• Thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and cGMP regulations
• Experience with Quality Management System (Deviations, CAPAs, Change Controls, and Effectiveness Checks) and SOP management as well as metrics reporting experience.
• Proficiency in the use of Microsoft Office, PowerPoint, and pharmaceutical GxP Digital Solutions (Experience with Veeva QualityDocs and Veeva QMS are the plus).
• Strong interpersonal, verbal, and written communication skills.
• Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management skills
• Proven ability to work independently

Education & Relevant Work Experience:

• Bachelor of Science (BS) degree in Science, Engineering, or related area of study
• A minimum of five (5) years prior experience, as a Quality professional in the biopharmaceutical industry.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• A working knowledge of cGMP requirements in clinical or commercial biologics.
• Excellent verbal and written communication skills including technical writing.
• Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products.

Physical & Travel Requirements:

• Some travel may be necessary.

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.