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Tara L. Greene BioEthicA and Inozyme

Pharmaceutical industry expert with over twenty (20) years’, in industry, regulatory, business and consultancy expertise; as a former FDA Pharmaceutical Inspectorate and pharma-industry experience setting her apart from the rest. Tara's proficiency spans all aspects of the manufacturing, compliance and quality arenas in drug governance from small molecule, and radiopharma to parenteral and biotechnology drug products; not limited to CDMO's, API, fill/finish; clinical development and commercial production. From start-up organizations to large, mature corporations; Tara has led her teams, coaching and mentoring key staff in executive management and junior positions, in regulatory strategy, operations, and quality systems. A brief history includes but is not limited to:

Vice President Quality & Compliance, Inozyme Pharma, Inc. Tara Greene joined Inozyme Pharma in September 2019 and serves as Vice President of Quality and Compliance. In this role, Ms. Greene is responsible for developing and leading the quality management and compliance systems at Inozyme and establishing a robust company culture.

Owner – Principal Consultant, BioEthicA, LLC: BioEthicA LLC is a global consultancy service specializing in pharmaceutical, biotechnology and biologics quality, compliance, regulatory and organizational development within the life sciences and health authority arenas. BioEthicA was founded on a culture of quality and quality by design philosophy and methodology. The business strives to ensure and deliver the ultimate safeguarding of biologics, drugs, devices and combination products for human consumption from early phase clinical trials to commercialization. www.bio-ethica.net

Interim Vice President and Quality Consultant Brammer Bio: Established a new QMS system for a cell and gene therapy CDMO based in Gainesville FL, and Cambridge Mass. Responsible for API, finished drug product and client Quality Systems, external and internal audit programs, quality agreements, organization and personnel. Established quality KPIs and developed policy and procedure to support the new business as a consultant and interim head of quality.

Global, Biologics and Small Pharmaceutical Client assistance and experience

•Conducted due diligence and compliance audits, vendor audits, oversaw vendor/supplier remediation to observations, authored reports and findings from audits and remediation

•Conducted Pre-Approval Inspection readiness audits and conducted remediation and 3rd party release for products under FDA review.

Radiopharmaceuticals

•Conducted FDA inspection readiness assessments, facility and staff walk-throughs with coaching and training in health authority inspection interactions. Conducted microbial investigation and EM remediation, advised on policy and procedure for regulatory compliance, data integrity (DI) and part 11 compliance audits and DI gap remediation including good documentation practices.