Timothy J. Kuhn

Current

• Manager, Clinical Quality Assurance - CSV at Celgene

Past

• Senior Specialist, GCP at sanofi-aventis
• Manager, Clinical Quality Assurance at Eisai Medical Research
• Validation & Technical Support Analyst at Merck & Co.

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Education

• American Society for Quality
• State University of New York College at Geneseo

Recommended

1 person has recommended Timothy J.

Connections

218 connections

Industry

Pharmaceuticals

Websites

• My Website: The GxP Zone

Timothy J. Kuhn’s Summary

A diversified Quality Professional possessing solid pharmaceutical auditing experience coupled with strong technical and problem solving skills.

Timothy J. Kuhn’s Specialties:

• Experience leading cross-functional and international audit teams
• Well-versed in pharmaceutical GxP compliance with particular focus on GCP and cGMP
• Familiarity with CFR and ICH
• Extensive background with computer validation, 21 CFR 11 , and SLC documentation
• Strong scientific background and familiarity with analytical pharmaceutical testing
• Experience managing international projects (Japan, Singapore, EU, Latin America, etc.)

Timothy J. Kuhn’s Experience

• Manager, Clinical Quality Assurance - CSV

  Celgene

  (Public Company; 1001-5000 employees; CELG; Pharmaceuticals industry)

  February 2008 — Present (1 year 6 months)

• Senior Specialist, GCP

  sanofi-aventis

  (Public Company; 10,001 or more employees; sny; Pharmaceuticals industry)

  August 2005 — February 2008 (2 years 7 months)

  • Independently initiate, prepare, and conduct audits as part of a systemic audit plan of the sanofi-aventis global clinical research programs
  • Report findings to the Functional Areas
  • Follow up on audit findings and identify compliance trends to Senior Management
  • Serve as the Quality and Compliance representative to internal project teams
  • Mentor and actively participate in knowledge sharing in the areas of regulatory compliance and industry best practices

• Manager, Clinical Quality Assurance

  Eisai Medical Research

  (Public Company; 201-500 employees; Pharmaceuticals industry)

  March 2003 — August 2005 (2 years 6 months)

  • Led the Quality Systems Unit for a global pharmaceutical research company, delegated projects to QA team members, and coordinated resource and budgetary planning
  • Provided internal functional areas and senior company management with actionable compliance assessments of the systems and processes that support Eisai’s clinical research program based on an objective program of internal and external audits
  • Provided strategic guidance for all aspects of Computer Validation and 21 CFR 11 compliance
  • Mentored and trained junior auditors, as well as cross-trained senior staff on validation auditing

• Validation & Technical Support Analyst

  Merck & Co.

  (Public Company; 10,001 or more employees; mrk; Pharmaceuticals industry)

  March 1998 — March 2003 (5 years 1 month)

  • Developed and evaluated analytical testing methods, and provided on-site technical support for their use in cGMP/GLP Laboratories worldwide.
  • Authored procedural, technology transfer, and validation documentation for internal and FDA review
  • Devised and implemented laboratory user-interfaces in support of electronic data security, 21CFR 11 System Life-cycle initiatives, and “Class A” Operational Excellence through continuous process improvement planning
  • Facilitated technical training and managed the maintenance, qualification, and allocation of laboratory instrumentation and equipment
  • Spearheaded time-critical manufacturing abnormality investigations

Timothy J. Kuhn’s Education

• American Society for Quality

  CQA , Quality Assurance Auditing , 2005 — 2005

• State University of New York College at Geneseo

  1991 — 1995

Additional Information

Timothy J. Kuhn’s Websites:

• My Website: The GxP Zone

Timothy J. Kuhn’s Interests:

quality, novel science, pharmaceutical development, technology, a better way, process improvement,

Timothy J. Kuhn’s Groups:

Society of Quality Assurance, American Society for Quality, Drug Information Association, The Blogosphere

•    Enterprise Architect (Sparx Systems) User Group
•    Sanofi-Aventis Network
•    Lifesciences Opportunities in US
•    Pharmaceutical Discussion Group
•    Good Clinical Practice
•    CLINICAL GLOBE
•    Geneseo Alumni Association
•    Getting Things Done (GTD) - David Allen Network of Innovators
•    Computerized Systems Validation
•    Biotech & Pharma Professionals Network
•    Quality & Regulatory Network
•    Merck and Co. Network
•    SQA - Society of Quality Assurance
•    Governance, Risk and Compliance Management (GRC)
•    CDISC Advocates
•    eClinicalNetwork
•    Clinical Research Careers (Global)
•    Electronic Data Capture - Clinical Trials

Timothy J. Kuhn’s Honors:

• Eisai On-the-spot Awards, Eisai Inc., 2003 and 2004. Received awards recognizing contributions in support of 21 CFR 11 compliance of Eisai’s Safety Reporting and Biostatistics/Data Management

• Corporate Recognition, Merck, Sharp, & Dohme, Ltd., 2001. Received in recognition of successful technology transfer to a new Singapore manufacturing facility

• Award for Excellence, Merck & Co., 2000. Received in recognition of Production “Abnormality/Atypical” investigative work

Timothy J. Kuhn’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch