Principal Quality Specialist - 2399

Editas Medicine

Editas Medicine

Quality Assurance
Cambridge, MA, USA
Posted on Monday, August 7, 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.

Key Responsibilities & Accountabilities:

  • Provides quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification of the digital manufacturing strategies.
  • Identify digital advancement opportunities for quality and lead their implementation while ensuring Quality Processes are adhered to or adjusted as appropriate
  • Collaborate cross functionally and across the Editas Enterprise/Network to ensure digital advancement is implemented in accordance with established procedures and applicable regulations. Partner with other facilities in the network to ensure implementation of standard processes, consistency, and continuous improvement.
  • Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports.
  • Ensures that all activities & related documentation comply with applicable regulations and Editas requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Own quality related Standard Operating Procedures, Work Instructions, Forms.
  • Ensure relevant processes, equipment, system are validated and the validation is current.
  • Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
  • Drive Support Continuous improvement and Operational Excellence initiatives
  • Assure Compliance of GxP digital systems in alignment with system regulations (21 CFR Part 11, GMP regulations, GAMP, Annex 11)
  • Provides Quality guidance and oversight of the procurement, installation, validation, integration, modification, operation and maintenance of existing or incoming eQMS designated for GMP.
  • Quality Lead for the implementation and maintenance of Oracle Supply Chain Management and associated tools (e.g. barcoding solution).
  • Collaborate with Business Owners to develop business case for new proposed GxP digital solutions.
  • Perform formal Request for Proposals (RFPs) to evaluate vendor alignment with business and technical requirements.
  • Collaborate with Functional Departments on business requirements gathering, requirements analysis, user testing, and system validations as needed.
  • Maintain external landscape awareness to communicate and ensure alignment with computer system regulations and guidelines that impact GxP digital solutions as they evolve.
  • Drive GxP digital solution governance program ensuring systems are maintained in a state of control.
  • Lead the development and execution of an operational data quality, data governance and data integrity management plan including processes and tools that deliver integrals quality data used to support GxP decision making.
  • Assess data integrity across business systems through the utilization of tools, dashboards, and analytics to identify and mitigate risks, inconsistencies, and identify areas for continuous improvements.
  • Collaborate with system owners to evaluate proposed changes to or troubleshoot problems with existing configurations, master data, data selection lists, integrations, and data reports.
  • Ensure the performance of periodic security and data integrity review of GxP Digital Solutions.
  • Ensure the quality oversight of validation activities for GxP Digital Solutions.

Knowledge, Skills & Capabilities:

  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
  • Working knowledge of current Good Manufacturing Practices (cGMP – 21 CFR Part 210/211) and Electronic Records; Electronic Signatures (21 CFR Part 11).
  • Working knowledge of GxP Digital Solution validation.
  • Proficiency in the use of Microsoft Office, PowerPoint, and pharmaceutical GxP Digital Solutions.
  • Experience with management and implementation of GxP Digital Solutions.
  • Demonstrated experience managing programs established to ensure the integrity of data across the organization.
  • Good Presentation development and performance skills.
  • Good verbal and written communication skills
  • Quality professional with hands-on experience with GxP Digital Solution implementation and maintenance in a regulated industry.
  • Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
  • Demonstrated organizational skills to managing multiple projects and priorities.

Education & Relevant Work Experience:

  • BS Degree in Life Sciences or equivalent
  • Minimum of 5 yrs. experience ensuring GxP Digital Solution quality.

Physical & Travel Requirements (if applicable):

  • Travel 35% of the time

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.