Lisa Podbielski

Associate Vice President, External Manufacturing Quality @Merck

Bedford, NH, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2016 — Present

Associate Vice President, External Manufacturing Quality @Merck

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Whitehouse Station, NJ, US

Direct all of the Quality and Compliance activities for external manufacturing of Pharmaceutical Drug Product globally.

EDUCATION

1979 — 1983

University of Arizona

Bachelor’s Degree, Chemistry

1983 — 1986

Boston College

M.S., Chemistry

SKILLS

CapaBiotechnology21 Cfr Part 11Pharmaceutical IndustrySopFdaCorrective and Preventive Action (Capa)GlpQuality SystemV&VChange ControlGmpTechnology TransferGxpCross-Functional Team LeadershipQuality AssuranceRegulatory AffairsValidation

ABOUT LISA PODBIELSKI

Strategic, results oriented executive with 25 years of pharmaceutical drug experience.Comprehensive knowledge of cGMP, FDA, EMEA, ICH, PICs and WHO requirements for drug substance, drug product development and commercial manufacture.Proven success in drug development and quality system implementation from IND through product commercialization (both sterile and non-sterile production.)Proven ability to troubleshoot and develop creative, innovative solutions to business challenges; successfully manage change for improved performance and efficiency.Proficient in hiring, training and supervising technical and support staff at all levels, encourage new ideas, and cultivated a creative team atmosphere to attract and retain quality people.Experienced in building business through equity expansion, system implementation, expense control and oversight for international operations.Well versed in intercultural communication and business practices; held positions located overseas (Belgium, Singapore) traveled to client sites in Latin America, Europe, Middle East and Asia.

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Lisa Podbielski — Associate Vice President, External Manufacturing Quality at Merck in Bedford, NH, US | Unifers