Associate Director/Director, Quality – 1136 – Boulder, CO

Job Description

Location – Boulder, CO

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.

Reporting to the Head of Quality in Cambridge with a matrix reporting to the Site Head at the Boulder site, the AD/Director Quality will be responsible for the development and implementation of the Quality Management System to support GMP operations at the Boulder site. This new role on the Editas Quality team provides a unique opportunity to contribute to the clinical translation of CRISPR technology by managing efforts that support the development and operationalization of Editas’ clinical programs.

This position’s responsibilities include but are not limited to: overseeing all internal quality activities including managing the evolving internal document management system, provide compliance oversight to applicable internal quality activities, maintain internal documentation processing functions and organizational records management. In addition, the qualified candidate will be expected to identify gaps in the current quality system, propose viable solutions and lead the process for improvement.

Responsibilities will include:
•Lead Quality operations for Editas’ gRNA and bulk RNP clinical manufacturing facility in Boulder, CO.
•Compliance oversight of the Boulder plant start up including design, commissioning and qualifications activities.
•Lead the activities for equipment qualification and collaborate on the development of process documentation.
•Manage final disposition of raw materials, gRNA and bulk RNP and labelled/ packaged material for the Boulder operations.
•Compliance oversight of the implementation, or tech transfer of analytical methods for testing of in-process, and release testing for gRNA and bulk RNP and reference materials at the Boulder site.
•Manage/participate in the implementation of applicable method qualification and validation programs for QC assays used to support raw material, in-process, release, and stability testing. Monitor the validation of safety testing to ensure compliance to internal procedures and guidelines.
•Manage the timely interpretation of testing results and trending of data to ensure conformity with quality specifications, including review of assay performance to ensure methods and results are as expected.
•Establish, implement, maintain, improve, monitor and report on quality and compliance systems. Ensure quality training is conducted to meet Edita’s requirements and regulatory agency’s expectations. Establish requirements for implementation of Quality Systems at the Boulder site to drive improvement and compliance.
•Process internal controlled documents including but not limited to: SOP’s, forms, batch records, templates, internal reports, engineering documents, etc.
•Assist with SOP and other controlled document generation including authoring, revisions, word processing and related database management. Review and approve internal documents ensuring compliance with applicable standards.
•Coordinate and track relevant activity at CMO’s.
•Correspond with external partners
•Maintain and track internal training program
•File, track and maintain controlled documents
•Participate in external audits in compliance with internal procedures including CMO’s, CTO’s and supplier audits.
•Review internal and external manufacturing documentation in support of GMP activities (batch records, analytical data, etc).
•Continue to build Editas’ Quality Management System (Quality Manual, SOPs, Training Programs, Approved Vendor List, Vendor Audit Program, etc.) for the Boulder facility.
•Work with the technical teams to ensure the development of robust data management systems to support internal process and release data, storage, and trending.
•Assist in the preparation of CMC regulatory submissions
•Direct and conduct internal audits to ensure compliance to quality system requirements and product specifications.
•Develop and manage the departmental budget and setting of short- and long-term department goals.
•Support regulatory document review and submissions

Minimum Qualifications:
•B.S., M.S., or PhD preferred in a scientific discipline with 15+ 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.
•Extensive experience managing Quality systems and activities.
•Excellent verbal and written communication skills.
•Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
•Experience managing early phase Quality, both internal and external, required and experience with late phase Quality preferred.
•A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred
•Experience with biologics in a biotechnology setting is required, and experience with protein, RNA, cell and/or viral products preferred.
•Understanding of regulatory guidance on cell and gene therapy products
•Expertise working within cGMP compliance and providing GMP documentation.
•Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making.

We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.