Senior Director, Quality Control

Our Opportunity...

We are looking for a highly motivated Senior Director, Quality Control, with a strong background in Cell Therapy and experience in BLA readiness. As a key contributor within the Technical Operations Team and player-coach, you will lead Quality Control activities supporting the development of our first clinical-stage autologous cell therapy program targeting solid tumors and drive a culture of rigorous thinking, exceptional collaboration and transparency, continuous learning, and outcomes focus. 

The selected candidate will be responsible for establishing and executing phase-appropriate QC strategies, ensuring analytical and testing operational readiness, and driving oversight of CDMOs and external testing partners in support of product quality, regulatory compliance, and clinical advancement. You will provide subject matter expertise and strategic and operational leadership for the QC organization, aligning QC vision, phase appropriate strategies, and activities with CMC and corporate objectives to ensure scientific, operational, and compliance excellence.  

You will be a vital part of a highly collaborative team working to achieve 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 is a hybrid role based out of our Bedford, MA location. 

You Will...

• Develop and implement a phase-appropriate QC strategy and operations for clinical and commercial stages of development to support external manufacturing of autologous cell therapy products ensuring compliance with regulations and alignment with applicable global standards. 
• Serve as the QC subject matter expert (SME) for analytical methods, method qualification/validation, CMC strategy, regulatory filings, relationship management with external laboratory partners, and interactions with regulatory agencies. Ensure methods are fit-for-purpose, phase-appropriate, and robust for QC environments. 
• Define analytical control strategies for drug substance (DS) and drug product (DP), raw materials, in-process controls (IPCs), and release testing. 
• Champion continuous improvement to strengthen method lifecycle management, documentation practices, and analytical robustness. 
• Partner with External Manufacturing and QA Operations to manage and oversee contract testing laboratories (CTLs) and CDMOs; lead method transfer, qualification, testing, validation, and lifecycle management in line with business needs and quality and regulatory standards.  
• Support lot release and disposition decisions in collaboration with QA including QC input into Investigations and CAPAs, change controls (methods, specifications, materials), and stability programs. 
• Review and approve internal and external documents (including laboratory investigations, deviations, CAPAs, SOPs, validations, reports, forms, specifications, and certificates of analysis). 
• Interpret and present data, perform statistical analysis, and conduct trend assessments, participate in Quality Management Reviews  
• Author and/or review CMC documents pertinent to quality control for regulatory submissions. 
• Lead QC support for Regulatory inspections for internal and external audits. 
• Oversee QC assessment of new raw materials and raw material qualification required to support GMP manufacturing and testing. 
• Establish department and individual goals and key performance indicators in alignment with company and operational goals. 
• Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues. 
• Develop and support a high performing team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee engagement and development, and philosophically aligned rewards and recognitions practices. 
• Drive a team culture of high standards, collaboration, empowerment, accountability, trust, and continuous learning. 

You Bring...

Core Qualifications

• PhD or MS in Biology, Biochemistry, or a related field, with 12+ years of experience in biopharma including cell therapy, demonstrating progressive responsibility in QC and Analytical Development or related function.  
• Expertise with cell-based potency assays, flow assays, immunoassays, molecular assays, and safety assays including rapid sterility and mycoplasma, and viral vector analytics.   
• Experience authoring and supporting BLA submissions. 
• Demonstrated success in leading outsourced/virtual QC models, partnering with Contract Manufacturing and Testing labs (CDMOS and CTLs) in technical transfer, qualification and validation of assays. 
• A track record of building and leading teams to deliver critical goals while adapting to changing priorities. 
• Exceptional communication skills in verbal, written, and visual formats, and adapted to the audience. 
• Excellent organizational skills; able to manage multiple tasks of varying degrees of complexity in parallel. ​ ​ 
• Ability to travel up to 20% of the time. 

Bonus Qualifications...

• Experience with T cells and/or TILs cell therapies. 
• Experience with rapid release of autologous cell therapy products. 
• Experience with gene therapy, including retroviral or lentiviral vectors. 
• Quality and compliance experience in a commercial GMP environment.