Senior Manager, Quality Compliance

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 Operations 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 Senior Manager, Quality Compliance with a strong background in quality compliance, external and internal audits, supplier management, and regulatory inspections to contribute to strengthening Obsidian’s overall Quality Management System. In this role, you’ll work collaboratively and cross-functionally to manage Obsidian’s network of GMP suppliers.

As a member of our Quality team, you'll be a vital part of a highly collaborative team working to achieve the Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.

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.

This position is a hybrid role based out of our Bedford, MA office (work on-site is optional except as required for training, team meetings, and other essential activities).

You will…

• Own the Quality Compliance and Audit programs to ensure alignment with FDA, ICH, and applicable GxP regulations; maintain phase-appropriate and risk-based quality systems across Technical Operations, Supply Chain, and Quality functions as well as with GMP CDMO suppliers

• Prepare for, schedule, and conduct audits of Obsidian’s GMP suppliers including CDMOs, contract testing laboratories, logistics providers, and other suppliers; generate an audit report and report findings to management and impacted stakeholders

• Follow up with audit findings to ensure effective remediation and CAPA execution, ensuring overall supplier performance

• Trend audit findings to identify systemic issues and improvement opportunities, and report at Management Review

• Execute internal audits and support regulatory inspections as necessary

• Onboard and qualify new suppliers and establish Quality Agreements with suppliers as necessary

• Regularly maintain the Approved Supplier List

• Author, review, and maintain SOPs governing Supplier Management, Audits, Quality Agreements, Supplier Corrective Action Requests, and Regulatory Inspections

• Champion a proactive quality culture focused on accountability, transparency, and risk-based decision-making

• Up to 30% business travel (essential requirement)

You bring…

Core Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline with 8+ years of relevant work experience (or M.S. and 6+ years of experience).

• 4+ years of biopharmaceutical experience in a related Quality function, cell or gene therapy strongly preferred

• Direct auditing experience of GMP suppliers such as CDMOs or contract testing laboratories, cell or gene therapy preferred

• Experience in clinical-stage environments

• Excellent knowledge and understanding of applicable GXP regulations

• Strong record-keeping and organizational skills, including an ability to manage multiple responsibilities in parallel

• A highly collaborative working style. You build trusting relationships, invite and share ideas and feedback, productively challenge your own and others’ assumptions to generate new ideas and facilitate better outcomes. 

Bonus qualifications

• Certified Quality Auditor (CQA) certification

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.

Anticipated Base Salary Range
$151,500—$185,000 USD

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.