Andrew Krall

Sr Director, Quality and Compliance @Vertex Pharmaceuticals

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2022 — Present

Sr Director, Quality and Compliance @Vertex Pharmaceuticals

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Boston, MA, US

Provides strategic leadership and direction to the advancement of the framework, capabilities, scalability, and sustainability of the compliance function in driving leading practices and keeping pace with the evolving organization and industry. Leads a team of compliance experts in ensuring compliance and inspection readiness across the Quality Management System through providing leadership, consultation, and advice to GxP areas. Directs and leads the design, execution and continual improvement of proactive compliance oversight strategies and programs for independent oversight of operational execution, effectiveness of quality systems and standards, and adherence to internal and external regulatory requirements and expectations

EDUCATION

1984 — 1988

Lebanon Valley College

BS, Chemistry

1989 — 1991

Drexel University

MBA, Operations Management

SKILLS

CapaLimsPharmaceutical IndustrySopFdaGxpQuality AuditingBiopharmaceuticalsGlpTechnology TransferGmpChange ControlCorrective and Preventive Action (Capa)ValidationCleaning ValidationGampQuality AssuranceRegulatory AffairsComputer System ValidationRegulatory RequirementsQuality ManagementRegulatory SubmissionsQuality SystemV&VU.s. Food and Drug Administration (Fda)

ABOUT ANDREW KRALL

Demonstrated progression of increased responsibility within the healthcare industry. Background includes broad knowledge in biopharmaceuticals, vaccines, pharmaceuticals, combination devices, cell therapy and consumer products with emphasis on application of cGMPs from a quality assurance and regulatory compliance perspective. Areas of expertise include new product introductions, implementation of quality systems, regulatory inspection readiness, auditing of GMPs, root cause analysis and risk mitigation, proactive approaches, and product lifecycle management.

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Andrew Krall — Sr Director, Quality and Compliance at Vertex Pharmaceuticals in Philadelphia, PA, US | Unifers