Manager, Quality Operations

Overview

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDrive

TM 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 are committed to an inclusive environment where each person feels a strong sense of belonging and is supported to learn and contribute their best work.

Our Research team is based in Cambridge, MA, and Technical Operations is based in Bedford, MA. Obsidianites enjoy a collaborative culture, competitive salary and benefits, and potential ownership through stock options.

We’re looking for a motivated, experienced, purpose-driven individual for the Manager, Quality Operations position. In this role, you’ll plan, coordinate, and execute critical quality initiatives that ensure full regulatory compliance and support corporate objectives. You’ll provide quality oversight of CDMO manufacturing of our drug product and other critical materials used in GMP-regulated environments. You’ll collaborate cross-functionally with internal teams and external partners to support Obsidian’s mission, starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.

This hybrid role is based out of our Bedford, MA office (onsite work is optional except for training, team meetings, and other essential activities).

• Support oversight of CDMOs to ensure adherence to GMP regulations and Obsidian Therapeutics’ requirements.
• Participate in plant/site activities.
• Provide QA support for manufacturing operations including CMC, QA operations, and supply chain/materials management.
• Manage lot disposition by reviewing batch data, deviations, in-process data, EM data, QC release testing, and other quality systems to determine product acceptability.
• Archive batch records and other disposition documents in internal repositories.
• Provide QA support for change controls, GMP investigations, CAPAs, and effectiveness checks.
• Facilitate timely resolution of quality issues.
• Lead investigation/CAPA triage meetings and collaborate with CDMOs and internal partners to ensure quality systems are monitored and metrics are met.
• Participate in IND preparedness, inspection readiness, and regulatory site inspections.
• Support development of quality metrics and participate in process improvement initiatives, gap analyses, and risk communication.
• Provide compliance guidance to project teams and collaborate with business owners to understand needs.
• Review applicable Supplier Quality Agreements.
• Travel up to 20% to perform essential job functions.

• Bachelor’s degree in Biology, Chemistry, Engineering, life sciences or related field with 6+ years of relevant experience (or MS with 4+ years).
• Strong knowledge of SOPs, CMC regulatory considerations, and quality system processes.
• Proficiency in QA oversight of GMP manufacturing, including batch release; experience with CDMO manufacturing and testing.
• Experience in quality-to-quality interactions with CDMOs/CTLs; RCA and CAPA experience.
• Experience with paper and electronic QMS systems; electronic QMS implementation is a bonus.
• Excellent planning, coordination, and time management skills; strong communication abilities.
• Ability to build and maintain productive relationships across the organization.
• Ability to manage multiple projects in a fast-paced environment.
• Systems thinking and sound judgement with context-based problem solving.

Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is $129,000—$157,500 USD and will be determined based on qualifications, education, experience, location, and internal equity. The package includes an annual incentive bonus, long-term stock options, and a comprehensive benefits program (medical, dental, vision; HSA; retirement contributions; paid time off; wellness programs; career growth opportunities).

Equal Opportunity Obsidian is proud to be an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other legally protected characteristics.