• careers

  • careers

Robert C. Lesnefsky

 

Bob Lesnefsky 105x145

Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences.

He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries.

Bob has proven experience with diverse facets of conducting business operations internationally and domestically at both the strategic and tactical levels and extensive experience with quality management tools and techniques, business process re-engineering and software quality assurance, including SEI CMM.

Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.

Bob’s extensive background includes:

  • Responsibility for compliant drug product manufacturing, labeling, packaging and distribution including validation of facilities, utilities and packaging equipment, including blistering, bottling, carding/cartoning and vision systems as well as computer systems validation including building management system, environmental monitoring, electronic batch records, manufacturing, computerized maintenance management & metrology, warehousing/inventory management and distribution systems.
  • Successful relationships as the primary contact for all regulatory agency inspections (FDA, DEA, MHRA, EPA, OSHA & FAA).
  • Responsibility for formal corrective/preventive action responses to FDA, MHRA, DEA and other regulatory bodies.
  • Implemented a CAPA system to track, monitor, assess potential trend and perform periodic evaluations of deviations, complaints and audit observations to ensure completion and effectiveness of corrective action plans.
  • Established and led the Global audit Program of Fisher clinical manufacturing, packaging, labeling and distribution facilities worldwide in Latin America, Europe, Canada and India as well as supplier qualification/audit program.
  • Managed the Quality Unit, the Quality Management System, cGMP compliance and all QA and Regulatory compliance functions for Fisher Clinical Services’ North American facilities including; internal, client regulatory agency and supplier audits, batch records, change control, product complaint & deviation investigations, deviation/audit/quality issue management evaluation, trending, escalation and resolution, product release, QA agreements and validation of all computer systems, equipment, facilities and processes.
  • Through the global audit program, identified and remediated weaknesses in practices across the enterprise and harmonized global best practices across all Fisher sites worldwide. This included successfully leading several global “best practices” harmonization initiatives including Global cleaning validation program, Global Computer Systems Validation Program, Global blister qualification test-to-failure strategy and Global Trackwise CAPA, Deviation, NCR, Investigation and Audit Programs across all Fisher North American, Latin American, European and India facilities.
  • As the Senior Manager of Bearing Point’s Life Sciences practice, Bob was instrumental in BearingPoint’s Public Services Organizational business unit establishing and achieving Capability Maturity Model Integrated (CMMI) Level 3 certification.

He is a Project Management Institute (PMI), Project Management Professional (certification #235244), an American Society for Quality Certified Manager of Quality/Organizational Excellence (certificate #9485), Certified Quality Auditor (certification #31740), an RAB ISO-9000 certified Auditor (certification #Q095571) and certified SEI CMMI Appraisor.

 

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials