Join Our Team
Director/Senior Director, Quality Systems
Bedford, MA
About Us…
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Development, Manufacturing, and Quality team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
Our Opportunity…
We’re looking for a highly motivated Director- or Senior Director-level leader to design, implement, and maintain an organization-wide quality management system (QMS), ensuring that all processes, products, and activities comply with Obsidian’s internal policies and external regulatory requirements to ensure patient safety and company integrity.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You will...
- Oversee audit readiness and foster a Quality culture focused on Right First Time (RFT) and Continuous Improvement (CI) with CMO partners.
- Manage Obsidian’s Document Control and Training program (e.g., SOPs, forms, specifications, electronic and master batch records, and records retention).
- Oversee all aspects of the QMS, including the management of deviations, Corrective and Preventive Actions (CAPAs), change controls, product complaints and Quality Review Board.
- Ensure regulatory compliance to 21 CFR Parts 201, 211, 1271, and ICH guidelines.
- Implement and oversee a risk management program to identify, evaluate, and mitigate risks associated with the QMS and product quality.
- Manage and oversee vendor qualification and audit program.
- Develop and monitor quality metrics and KPIs to track performance of external CDMOs
- Build, lead, coach, and develop a high performing team of Quality Systems & Compliance professionals.
- Prepare and Lead Quality Management Reviews.
- Ensure compliance with cGMP and internal procedures.
- Provide Quality Systems and Compliance guidance to cross-functional teams.
- Lead transition to eQMS system.
- Future - lead audits and inspections, serve as the primary liaison during regulatory inspections by health authorities and client audits. This includes managing inspection readiness, coordinating responses, and implementing corrective actions.
You bring...
Core Qualifications
- BS and 15+ years of biotech/pharma industry experience (or MS and 13+ years of relevant experience), including 8+ years in progressive Quality leadership roles in complex biologics (cell or gene therapy preferred).
- Deep understanding of GMP regulations.
- Significant experience overseeing quality systems and compliance for an externalized GxP environment with multiple CDMOs.
- Aseptic manufacturing experience
- A strategic, pragmatic, phase-appropriate, risk-based approach to Quality Systems based on experience in clinical to commercial stage.
- A successful track record of developing talented, engaged, and high performing teams.
- Scientific curiosity and an ability to understand the science underlying our drug product and process.
Obsidian is committed to equitable and transparent pay practices.
The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.
Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.