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Quality Systems Supervisor, Site Quality Assurance Operations - Waltham, United States - Editas Medicine
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.
Is this your next job Read the full description below to find out, and do not hesitate to make an application.
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.
Together, we are leading the way towards a healthier and more equitable future.
Description
Editas is seeking a cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations.
This position will be responsible for Quality Operations support of internal clinical manufacturing at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality Operations team.
Specific responsibilities include but are not limited to Quality support/oversight and leading initiatives related to:tech transfer and facility start-up, floor operations, QMS record review, MBR and SOP generation/revision, training, materials management, equipment management, and maintenance at the Editas Waltham and Editas Devens GMP manufacturing facilities.
Key Responsibilities:
Support Editas' clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team with primary focus on QMS records and technical reviews related to both Manufacturing and Quality Control.
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).
Establish, implement, maintain, improve, monitor and report on quality and compliance systems including management, review, or performance of associated trending.
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.
Requirements
Required Qualifications
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
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 required.
Expertise performing/assessing root cause analysis investigations required.
Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products required.
Preferred Qualifications
Experience leading and managing a team.
Experience with both early and late phase clinical manufacturing preferred. Experience with new product introductions or facility start-ups preferred. Experience providing quality oversight for QC strongly preferred.
Excellent verbal and written communication skills including technical writing.
Experience in both clinical and commercial or late stage clinical preferred. Experience with mammalian cells and/or gene therapies preferred.
Expertise performing/reviewing laboratory investigations strongly preferred.
Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making
Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
Physical & Travel Requirements:
Ability to gown into a cleanroom
Ability to support a morning or evening shift schedule.
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.
