John Rubright Email & Phone Number

Murrysville, Pa, Us

Tarrytown, Ny

Ensured quality system compliance during consolidation and expansion of NY sites; led GMP audits to assure compliance of internal processes and key external partners; monitored Germany-based policies and directives to assure sustained DC compliance; provided quality system leadership to key business processes.• Developed and led plan for integrating a 15-member company into the DC quality system including development of procedures for complaint handling and product service, and extensive preparation of design history files resulting in consistent processes.• Led key GMP compliance audits at five domestic sites and four global strategic suppliers focusing on new processes, products, and high risk activities to minimize regulatory risk.• Key contributor for SAP implementation project at Indiana-based sister location; included back-up organizational alignment representative duties and led development of procedure for implementing SAP security access for DC; recognition award received. • Assured execution of training, document control, CAPA investigations, and ISO 13485 recertification readiness for NY-based product development and marketing activities.• Executed three due diligence audits of Contract Research Organizations during one week to support urgent need for high priority product development project.

Leverkusen, Germany

Managed extensive global audit program covering BHC and contract sites for medical devices, pharmaceuticals, over-the-counter, biological, and animal health products. • Integrated medical device GMP requirements into pharmaceutical-based audit program; negotiated objectives, schedules, participation, logistics, and training with medical device QA leadership team. Provided independent confirmation of GMP compliance for BHC.• Scheduled, managed, and led corporate GMP audits focusing on 12 BHC medical device sites and strategic suppliers. Led 15-20 audits per year resulting in major improvements to quality system compliance.• Managed GMP audits of ten newly acquired contract sites for over-the-counter (OTC) production in the European Union resulting in major compliance improvements.• Performed multiple mock FDA audits leading to successful Pre-approval audits by FDA.• Trained senior auditors in effective writing skills for audit reports.

Pittsburgh, Pa

Led corporate GMP audits of BHC’s U.S.-based production sites for OTC, biological, pharmaceutical, animal health and medical device products; supported Bayer-Germany initiatives implemented in the U.S.• Led or participated as Subject Matter Expert in 10-15 audits per year.• Reviewed, analyzed, and recommended corrective actions to regulatory audits.• Assisted with development of corporate directives for 21 CFR Part 11 compliance.• Selected for international assignment supporting Germany-based QA organization.

Murrysville, Pa

Audited for GMP compliance driving improvements of internal processes, production affiliates in Hong Kong, China, and the Philippines, clinical investigators, and key suppliers.Conducted advanced QA assignments supporting corporate growth including due diligence audits, integration of acquired organizations, ISO-9001 certification, and supplier improvement.• Performed 10-15 GMP audits per year to medical device regulatory requirements.• Key contributor during 3 major acquisitions supporting rapid growth of the business.• Developed and implemented company-wide quality processes for off-site record storage, auditor certification, clinical trial auditing, and documentation of exported products.• Supported quality system certification to the Medical Device Directive and ISO-9001.

Pittsburgh, Pa

Performed inspections of Class II and III medical devices (Pre-Approval, in vitro diagnostics and sterile products), pharmaceuticals (Over-the-Counter, medical oxygen and New Drug Applications), and bio-research monitoring (Clinical Investigators, Institutional Review Boards, Investigational Device Exemptions). Performed 15-20 audits per year.• Promoted to Grade GS-12 with numerous cash awards/step increases for outstanding performance; awarded Commissioner’s Citation for Permanent Injunction of OTC firm.• Selected to Foreign Inspection Cadre for medical device inspections in Asia and Europe.

B.S., Biology

Activities and Societies: Blue Band, Phi Mu Alpha, Phi Sigma Society

M.S., Oceanography

Mba, General Business