Jeff Orlov
Senior Director, Global Quality Systems, Bristol Myers Squibb
- Role
- Senior Director, Global Process Owner, Global Quality Systems at Bristol Myers Squibb
- Location
- New Brunswick, NJ, US
- LinkedIn followers
- 500 followers
About Jeff Orlov
Accomplished Quality Systems professional with extensive experience in GMP regulations (US and EU), hosting European Health Authority inspections, auditing internal GMP facilities and contractors, designing and implementing global Complaint processes, global deviation/investigation systems, and global change management processes. Hosted two successful European Health Authority Inspections of NJ Pilot Plant both resulting in receiving EU GMP certification to manufacture and test several dosage forms. Fully integrated into Merck Production System (MPS) establishing tier processes, Toyota Kata principles and Inclusion methodology (focusing on the how, not just the what)Expertise in Consent Decree Management having been instrumental in guiding organization through extensive consent decree mitigation activities (20••••07)
Experience
Senior Director, Global Process Owner, Global Quality Systems
Jan 2020 — Present · New Brunswick, NJ, US
Accountable for the effective and efficient execution of the GxP Investigations, NTM and Health Authority Reporting global processes as well as ensure full compliance with all internal and external regulatory requirements•Accountable to ensure process optimization, company-wide integration, and long term sustainability following standard methodology•Align resources to drive process optimization for function and assure key accountability•Ensure role definition and clarity on key accountabilities for process steps through an enterprise lens•Lead and assure alignment of GxP document practices across the enterprise•Endorse defined optimization metrics to ensure Quality outcomes and monitor performance for associated processes.• Champion for an Enterprise-wide Quality mindset / Culture of Quality• Accountable for Global regulatory inquiries related to processes• Provide strategic leadership for establishing and maintaining robust compliant Investigations and Management notification programs across the end-to-end product lifecycle (GPS and R&D) and across all BMS sites and internal and external functions in alignment with relevant governmental regulations and guidelines
Education
Rutgers University
mini-MBA, BioPharma Innovation
2009 — 2009
University of Delaware
Bachelor's, Biological Sciences
1983 — 1988
Skills
- Biotechnology
- Capa
- Quality Auditing
- Quality System
- R&D
- Change Control
- Auditing
- Sop
- Gmp
- Change Management
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