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Quality management executive with over 30 years of diverse experience in global pharmaceutical, biopharmaceutical, medical device, and 503B industries. Public, private, global, venture capital, and private equity company experience. Expertise in regulatory compliance including current FDA, ex-US, and ISO requirements. Highly proficient in regulatory inspection preparation. Entrepreneurial mindset in building teams, designing business processes, and strategic planning. Success in gaining Board level endorsement for compliance improvement programs. Strong collaborator who thrives at continually improving business processes and managing multiple priorities in matrixed organizations. An excellent communicator who focuses on satisfying diverse customers and partner’s needs.Specialties: Pharmaceutical and biopharmaceutical manufacturing, strategic business planning, aseptic processing, technology transfer, quality management system design and implementation, new product introductions, complex root cause analyses and investigations, continuous improvement methodologies, quality operations, GMP inspection management, global leadership in matrix organizations, organizational change management and integration, company Board engagement (risk management, risk mitigation, compliance committee review, and continuous improvement efforts).
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Vice President, Quality And ComplianceTris Pharma Feb 2024 - PresentMonmouth Junction, New Jersey, Us• Lead the commercial Quality Assurance organization (Quality Assurance, Compliance, Quality Control) and active member of the Company Board’s Compliance Committee.• In 6 months, led the redesign of the Quality & Operations Business Meeting that reestablished meeting purpose, participation, and deliverables. Meeting now aligned to the Company’s strategic growth plan, key projects, and performance metrics. -
Sr Vice President, QualitySca Pharma Aug 2021 - Feb 2024Little Rock, Arkansas, Us• Member of the SCA Pharmaceuticals executive management team with responsibility for leading a multi-site, Quality Assurance organization (Quality Assurance, Quality Control, Microbiology) for an industry leading 503B Outsourcing company. -
Vice President, Us Quality AssuranceFerring Pharmaceuticals 2015 - 2021St-Prex, Ch• Member of the Ferring US executive management team with responsibility for leading the US Quality Assurance organization (Quality Assurance, Quality Control, Microbiology) through all development, clinical and commercial programs. Aligned US quality management system (QMS) with Ferring Global QMS requirements and partnered across global regions to meet all business goals and commitments. • In 9 months, assessed and gained executive approval to implement an integrated and harmonized quality assurance organization that leveraged key talent and QMS elements from three Ferring entities to create one QMS for all Ferring US operations. -
Vice President, Quality OperationsWindtree Therapeutics, Inc. 2011 - 2015Warrington, Pa, Usformerly Discovery Laboratories, Inc.• Member of the executive management team with responsibility for leading the Quality Operations organization.• Led a 30-person, multiple site, quality operations organization that realized successful product launches and ongoing lifecycle management for Surfaxin® and Afectair®, Discovery’s first two commercially available (drug and device) products. • Achieved first pass success in obtaining (and maintaining) ISO13485 certification.• Led a 15-person, inter-company technical transfer project that resulted in first pass completion of all development, qualification, and stability activities in support of an investigational new drug filing, and clinical study initiation.• Led a combination of eleven successful health authority inspections and notified body audits that resulted in product approvals, standard certification, and ongoing compliance with current standards and regulations. • In 10 months, led a 20-person quality operations organization that redesigned and implemented a multiple site, quality management system that realized two successful preapproval inspections and health authority approvals for the company's first two commercial products. -
Principal Scientist, Parenterals Platform, Global Technical ServicesThe Janssen Pharmaceutical Companies Of Johnson & Johnson 2009 - 2011Raritan, New Jersey, Us -
Director, Quality AssuranceThe Janssen Pharmaceutical Companies Of Johnson & Johnson 2004 - 2009Raritan, New Jersey, Us
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Associate Director, Quality And ValidationOrtho-Mcneil Pharmaceutical 2002 - 2004Jakarta, Id -
Business Unit Manager – Pharmaceutical Processing And PackagingOrtho-Mcneil Pharmaceutical 2001 - 2002Jakarta, Id
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Operations Excellence LeaderOrtho-Mcneil Pharmaceutical 2000 - 2001Jakarta, IdBlack Belt
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Facility Manager, Biological ManufacturingOrtho Biotech 1994 - 2000Basel, Ch
Michael Magee Skills
Michael Magee Education Details
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Moravian UniversityChemistry -
Saint Joseph'S UniversityPharmacy
Frequently Asked Questions about Michael Magee
What company does Michael Magee work for?
Michael Magee works for Tris Pharma
What is Michael Magee's role at the current company?
Michael Magee's current role is VP, Quality and Compliance.
What is Michael Magee's email address?
Michael Magee's email address is mi****@****ing.com
What is Michael Magee's direct phone number?
Michael Magee's direct phone number is +415830*****
What schools did Michael Magee attend?
Michael Magee attended Moravian University, Saint Joseph's University.
What skills is Michael Magee known for?
Michael Magee has skills like Gmp, Fda, Pharmaceutical Industry, Validation, Quality System, Technology Transfer, Quality Assurance, Biotechnology, Capa, Aseptic Processing, Medical Devices, V&v.
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