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Quality Assurance, Senior Manager/Associate Director (External)

Bedford, MA

Our Opportunity…

We’re expanding our Quality team to support manufacturing with a critical CDMO partner for our clinical trials in metastatic melanoma and non-small cell lung cancer. In this role, you’ll work closely with a dedicated team to initiate and oversee the manufacturing of our engineered autologous cell therapies. The ideal candidate will have experience directing and overseeing QA of drug product manufacturing completed at a CDMO, preferably in cell and/or gene therapy.  As part of our Technical Operations team, you’ll be a vital part of a highly collaborative team working to deliver OBX-115 to patients and achieve Obsidian’s vision of translating innovative science into medical breakthroughs.

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 will join a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

You Will…

• Provide QA direction and oversight for process and method transfer/validation, testing and release activities at external CDMO to ensure GMP compliance.
• Review and approve method transfer and tech transfer protocols and reports.
• Review master batch records, executed batch records, test methods, QC test documentation, COAs, COCs, and associated documentation to support timely release of clinical trial materials.
• Support development or review of SOPs and specifications.
• Direct investigation of quality events including laboratory investigations, OOS/OOT and deviations, complaints etc.
• Support development of quality metrics and risk assessment as needed.
• Support regulatory submission activities.
• Collaborate closely with QA, QC, Manufacturing, MSAT, AD and PD groups, and other key partners.
• Assist with continuous improvement of quality and compliance.
• Regularly perform QA Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.
• Participate in inspection readiness activities and provide support during regulatory site inspections.
• Participate in Obsidian IND preparedness.
• Participate in Vendor/Supplier Qualification activities (i.e. Audits, site visits).
• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.

You Bring…

Core Qualifications

• Bachelor’s degree in biology, chemistry, life sciences or a related field, and 8+ years of progressive QA experience in biotech (or MS and 6+ years).
• Strong CMC background and GMP quality background for ATMPs.
• Experience providing QA support and oversight of GMP manufacturing operations for cell and/or gene therapy products, including batch release.
• Experience with CDMO manufacturing and testing with proficient knowledge of cGMP's and associated CMC regulatory considerations.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Thorough knowledge of FDA and ICH regulatory guidelines and cleanroom environmental monitoring requirements.
• A clear sense of ownership and accountability to meet commitments and high standards, promoting the same with CDMO partners.
• A team mindset and highly collaborative working style – build trusting relationships, share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate better outcomes.
• Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment.
• Proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans.
• Systems thinking – You approach problem solving and process design from with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
• A track record of context-based sound judgement, including when to elevate risks and issues to leadership.
• Self-motivation and a demonstrated ability to work with general direction to meet objectives and timelines.
• Flexibility, ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient.
• An ability to be on-site at CDMO up to 30-40% of time (for day trips, the ideal location is mid-Atlantic; for other locations travel of this amount will be required).

Bonus Qualifications

• Experience with regulatory agency inspections.

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