Decoding The Role:The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes. This role is part of a collaborative QA team, offering opportunities to broaden expertise across multiple Quality disciplines. EDIT-401 is a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is excited by the potential of this experimental treatment, which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates.
Characterizing Your Impact:As the Senior Specialist, Quality Systems Management, you will:
- Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement.
- Support the administration, maintenance, and optimization of the electronic document management system (Veeva QualityDocs), electronic quality management system (Veeva QMS), and learning management system (ComplianceWire).
- Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination.
- Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials associated with Quality Systems.
- Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes.
- Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments.
- Assist with internal and external audits, inspections, and follow-up activities as needed.
- Identify opportunities for process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance.
RequirementsThe Ideal Transcript:To thrive in this role, you'll need:
- Strong experience administering and/or supporting electronic document management systems, Quality Management Systems, and learning management systems.
- Experience supporting vendor qualification, vendor management, and supplier auditing activities.
- Demonstrated expertise working within cGMP-regulated environments and managing GMP documentation.
- Working knowledge of ICH Q10, FDA regulations, applicable international regulatory standards, and regulatory expectations for clinical-stage biotechnology products, including gene therapy.
- Ability to work independently while collaborating effectively within a cross-functional, team-oriented environment.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent organizational and prioritization skills with the ability to manage multiple activities simultaneously.
- Experience supporting biologics, protein, RNA, cell therapy, gene therapy, viral vector, and/or related products.
- Bachelor's degree in a scientific discipline with 5-8 years of Quality Systems, Quality Assurance, or related experience within the biopharmaceutical industry.
Fundamentals That Set You Apart- Experience supporting Quality Systems within early-phase clinical development organizations.
- Hands-on experience with Veeva Quality applications.
- Auditor training and/or experience supporting supplier or internal audits.
- Experience supporting Quality Operations activities.
- Demonstrated ability to drive process improvements and support inspection readiness initiatives.
BenefitsEditas 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 Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
Salary Range: 103,000 - 119,000Pay TransparencyEditas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices.
Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases.
