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Associate Director, Quality Assurance Operations

Bedford, MA

Our Opportunity…

We’re looking for an individual with a strong background in Cell and Gene Therapy GMP Quality Assurance to contribute to the success of our first multi-site clinical trial and the development of Obsidian’s Quality practice.  In this role, you’ll collaborate with stakeholders on CMC (internal) and CDMO (external) teams to assure phase appropriate implementation of Quality systems and processes. As part of our Technical Development, Manufacturing, and Quality department, you’ll 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 currently evaluating patients with metastatic melanoma. This position is an individual contributor role at this stage, with a hybrid schedule based in our Bedford, MA location.

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…

• Partner with Process Development and MSAT, Analytical Development and QC, and Clinical Operations colleagues to strategically develop and implement phase appropriate approach to quality assurance and quality assurance systems.
• Be responsible for lot review/release activities for drug substances, drug products, and finished goods by CDMOs.
• Assure compliance with cGMPs and standards as well as regulations of applicable authorities by Obsidian and its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases.
• Conduct clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records. 
• Build and successfully manage Quality to Quality relationship with CDMOs, including periodic visits to CDMOs as required, and representing Obsidian QA on CDMO project teams.
• Establish and track Quality metrics, working with internal and external stakeholders.
• Together with a multi-disciplinary Obsidian team, support manufacturing, testing, and stability by external contract manufacturers and testing laboratories.
• Manage and address deviations, investigations, CAPAs, change controls, OOS, Material Review Boards, product complaints, etc. with associated CDMO.
• Implement necessary Quality Agreements.
• Assist in preparing or reviewing CMC sections of regulatory submissions as required.
• Conduct audits of CDMOs/ Testing Laboratories by overseeing vendor management.
• Provide QA support for regulatory inspections.
• Contribute to the development of Obsidian quality systems, processes, and procedures.

You Bring…

Core Qualifications

• Bachelor’s degree in biology, chemistry, engineering, life sciences or a related field.
• 10+ years of Quality experience in a cGMP environment, including late-stage drug development and experience in the Cell or Gene Therapy space.
• 6+ years in a Quality leadership role in a drug development company.
• Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations.
• Experience developing and managing successful third-party relationships, including CROs, contract manufacturing organizations and testing laboratories.
• Strong technical writing skills.
• Effective communication skills and ability to work in a diverse and dynamic environment.
• A track record of good judgment in elevating issues and determining solutions and actions in high consequence situations.
• Demonstrated ability to recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities.
• 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.
• Self-motivation and a proven ability to work with general direction to meet objectives and timelines.
• Flexibility, you adapt to changes and priorities to fulfill our mission.
• An ability to effectively manage and deliver multiple complex and consequential projects and priorities in parallel.
• A willingness and ability to travel domestically and internationally as required (estimated 25%).

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