Scott Schell Email & Phone Number

New Brunswick, NJ, US

• Member of the corporate JJRC Assessment and Remediation program designed to provide a cross-sector quality oversight for world-wide operations across the company and to escalate risks to the executive committee. JJRC.
• Auditing and Remediation of manufacturing sites from all 3 sectors; Pharmaceutical, Medical Device and Consumer Health Care
• Auditing and Remediation of Country Marketing companies and associated Distribution Centers.
• Auditing and Remediation of Corporate GMP Support groups.
• Perform directed For-Cause audits and Special Investigations.
• Perform External Manufacturing audits.

Paris, France, FR

• Provides oversight for the implementation and maintenance of multiple regulatory compliance functions supporting new and existing products worldwide. Manage compliance audit activities for GMP systems and processes.
• Oversee the implementation and maintenance of quality systems, corporate standards and policies.
• Interpret, execute and recommend modifications to organization policies and procedures.
• Perform GMP and ISO compliance audit activities in highly specialized technical areas and processes critical to the manufacturing and control of medical products.
• Provides expert technical and compliance support to Genzyme facilities for process improvements and preventive actions.
• Interface with external regulatory inspectors to address compliance problems or issues.

Rahway, New Jersey, US

• Member of the worldwide compliance audit program to ensure product is developed, produced, controlled, and stored in conformance with current Good Manufacturing Practices (cGMP), and other applicable governmental.
• Performed audits of human and veterinary drug manufacturing plants worldwide; drug dosage forms include biotechnology, vaccines, parenterals, tablets, liquids/ointments/creams, and active pharmaceutical ingredients.
• Performed mock pre-approval inspections (PAIs)
• Performed audits of distribution centers and warehouses
• Assessed the adequacy of the corrective action commitments made in responses to audit observations
• Tracked and verified the corrective actions after acceptance of the corrective action plan.

Tokyo, JP, JP

• Managed a team of Auditors in the Corporate Quality Audit Department for inspections of cGMP service/material suppliers
• Conducted audits of clinical and commercial drug and API manufacturers, laboratories, raw material suppliers, packaging and distribution sites
• International audit experience and training from Qualified Persons
• Drug products include tablets, capsules, and transdermals; including controlled substances
• Managed PAI readiness for Shire and contract vendor sites and perform mock regulatory inspections. Assisted vendors during regulatory inspections
• Completed audit reports and maintain Approved Supplier List

• Managed a team of 13 QA inspectors for the in-process inspection of all production activities and the release of raw materials, components and finished goods.
• Approved all quality documents within Clinical Services
• Hosted customer and regulatory audits
• Performed internal and external quality audits
• Managed the implementation of quality system software (Trackwise, Documentum, Eduneering and JD Edwards)
• Quality trainer, performing most quality and site training

New York, New York, US

• Plant Auditor (2002)Ensured that all production processes and support functions were in compliance with federal regulations and corporate guidelines
• Performed quality system audits of the manufacturing and laboratory areas
• Reviewed and assessed completion of Consent Decree commitmentsR&D Lead Investigator (2001 – 2002)Responsible for investigating, documenting, tracking and trending manufacturing discrepancies.
• Acted as liaison between Manufacturing and Quality Assurance
• Wrote and revised change controls, work orders, SOPs and production batch records
• Completed Consent Decree commitments and Gap AnalysisFormulation and Fill Supervisor (2000 – 2001)Oversaw all aspects of clinical vaccine manufacturing (Phase I-III)

Ms, Quality Assurance And Regulatory Affairs

Ba, Biology