Robert Pascoe
Director, Global Quality and Compliance at Merck
- Role
- Director, Global Quality and Compliance at Merck
- Location
- West Point, PA, US
- LinkedIn followers
- 500 followers
About Robert Pascoe
Director in Global Quality and Compliance, Quality Management System (QMS) Topic Owner for global analytical specification management and the end to end laboratory testing process(es) for all modalities.•Global business and process owner for GLIMS (Global Laboratory Information Management System) including ongoing effort for digitization of laboratory methods and worksheets.•Responsible for the strategy, codification and execution of global analytical specification management across >25 facilities and ≈1200 materials (drug substance, drug product, raw materials etc.) encompassing pharmaceutical, vaccine and biological modalities.•Led the day to day operation of a global analytical change control organization responsible for managing and executing analytical specification changes in support of regulatory, compendial and process driven updates. Working closely with Regulatory, Technical and Site Quality to ensure continue compliant supply of materials to the market.•Responsible for providing global analytical technical leadership, expertise and support for method validations, method transfers and troubleshooting of OOS, atypical events and product complaints across a multitude of APIs and dosage forms for pharmaceutical and consumer care products from launch through the product life cycle.•Responsible for authoring and review of Regulatory and Compendial documents/responses for commercial products.•Responsible for the professional and technical development of staff members assessing strengths and developmental needs, maintaining clear and concise objectives and employing career development plans.•Previously Responsible for the day to day operation of a GMP laboratory across multiple sites including documentation and instrumentation compliance, inspection readiness, staffing, capital planning, profit plan and budget operations, resource usage/allocation and safety performance and metrics.
Experience
Director, Global Quality and Compliance
Aug 2018 — Present · West Point, PA, US
Education
Drexel University
Ph.D., Analytical Chemistry
1998 — 2002
Skills
- Gmp
- Hplc
- Analytical Chemistry
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