
Cqa Margaret Hindley Cqe
OBJECTIVE As a proven compliance leader in Validation/CSV, Quality Systems, and Data Integrity, I am seeking a challenging opportunity... | Newtown Grant, Pennsylvania, United States
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Cqa Margaret Hindley Cqe’s Emails ma****@sp****.com
Cqa Margaret Hindley Cqe’s Phone Numbers No phone number available.
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Cqa Margaret Hindley Cqe’s Location Newtown Grant, Pennsylvania, United States
Cqa Margaret Hindley Cqe’s Expertise OBJECTIVE As a proven compliance leader in Validation/CSV, Quality Systems, and Data Integrity, I am seeking a challenging opportunity in the healthcare / pharmaceutical / biotech / emerging technology industries where my advanced skills, education, extensive training, and years of experience can be fully utilized. SUMMARY OF QUALIFICATIONS • Led QMS development for CSV and Data Management • Co-Developed a Validation Strategy/Playbook for AI / ML GxP projects • Enterprise Validation activities for Asset Predictive Optimization (IoT) and Real-Time Release Testing (IoT & ML) projects • Proven leader in Continuous Improvement and re-engineering of instrumentation, departmental, division, and sector processes and procedures, as well as implementation and training plans for CSV and Data Integrity • Proven track record of delivering compliance-based projects (i.e., CSV and qualification deliverables, Validation Master Plans, gap assessments, data integrity assessments, action plans, investigations, change controls, etc.) on time • Led Lab-based Data Integrity driven workstream for Inspection Readiness (Pre-FDA) covering all R&D Lab Operations • Experienced in Pharma, OTC, Monograph, and Cosmetic/Consumer products
Cqa Margaret Hindley Cqe’s Current Industry Taiho Oncology
Cqa
Margaret Hindley Cqe’s Prior Industry
University Of Pennsylvania
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Schering Plough Research Institute
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Merck
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Johnson And Johnson
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Mcneil Consumer Healthcare
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Taiho Oncology
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Work Experience

Taiho Oncology
Director, Computer Software Assurance
Tue Nov 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Johnson And Johnson
Sr. Manager Data & Analytics; Technology Quality
Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Johnson And Johnson
Sr. Manager Validation
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Johnson And Johnson
Manager, R&D Quality And Compliance (R&D Csv-Qa)
Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Mcneil Consumer Healthcare
Manager, R&D Compliance (Analytical/Micro)
Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Sr. Engineer
Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Schering Plough Research Institute
Supervisor/Group Leader
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Schering Plough Research Institute
Senior Scientist
Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
University Of Pennsylvania
Post Doctoral Scientist
Fri May 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)