Bristol-Myers Squibb Company

Auditor

Location
Princeton, NJ, US
Posted
Aug 29, 2018
Ref
R1508641
Required Education
Doctorate/PHD/MD
Position Type
Full time
Principal Objective of Position:

To conduct audits of preclinical Good Laboratory Practices (GLP) studies, with primary emphasis on the bioanalytical portions as well as audits of clinical biomarker work done under Good Clinical Laboratory Practices (GCLPs). The term "analytical" is used to describe data and reports generated by Translational Sciences, Bioanalytical Sciences and Toxicology.

Major Duties and Responsibilities:
  • Maintain an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the relevant Bristol-Myers Squibb Company policies and procedures associated with bioanalytical analyses supporting preclinical (GLP) and/or clinical (GCLP) research.
  • Provide advice and counsel concerning GLP, GCLP or other applicable regulatory requirements.
  • Conduct GLP and GCLP audits and inspections of bioanalytical, toxicokinetic, and biomarker ana1yses (both large and small molecule) supporting preclinical and/or clinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures:
    • Review study protocols, amendments and deviations.
    • Schedule and conduct inspections of bioanalytical activities.
    • Prepare and submit written reports of these inspections to study director and management.
    • Audit final reports and raw data for these studies.
  • Perform Quality System audits at various R&D sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance:
  • Compile documentation in preparation for the audit
  • Contribute to the writing of clear, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management
  • Review and assess corrective action plans and follow-up on the resolution of audit -findings.
  • Keep clear and detailed documentation on every audit planned, performed and followed.
  • Regularly update the audit database, generate, review and maintain required reports (e.g., inspection reports, etc.).
  • Assist in the preparation of departmental standard operating procedures.
  • Participate in the preparation and conduct of regulatory training (e.g., GLP and GCLP training) to be given to personnel involved in the conduct of preclinical and/or clinical studies.
  • Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, etc.).
  • Conduct other audits or investigations of regulatory concern as directed by GQ-QLP management.


Impact:
  • Bristol-Myers Squibb efforts are focused on discovering, developing and gaining approval of ethical drug products. The drug development process is governed by various regulations. Non-compliance with these regulations can result in a loss of or delay in marketing approval for new products and/or pose the threat of significant financial and legal liability to the company.
  • GQ-QLP is responsible for auditing a1l processes related to bioanalytical studies supporting preclinical and/or clinical research to assess compliance with relevant regulations. This position is expected to be involved in all aspects of GQ-QLP operation.


Decision Making:
  • This position is responsible for regularly evaluating key bioanalytical processes to determine compliance with regulatory requirements and established standard operating procedures. Noncompliant situations must be identified and appropriate corrective and preventative actions recommended. Recommendations must be ethical, scientifically sound, consistent with company policy and strategy, and cost-effective. Good judgment and a sense of discretion are required given the potential risks and consequences of the decisions.
  • Audit and inspection strategies and priorities are established with supervisory oversight. Minimal supervision is received during the actual performance of duties. Job results receive careful supervisory review.


Contacts and Stakeholder Groups:
  • Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow-up of audits.
  • Regular and appropriate contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
  • Interaction with scientific and managerial personnel at contract research organizations during evaluation of these facilities (4-6 times/year).
  • Close working relationship with external auditors and inspectors (FDA, etc.) during the conduct of their inspections (1-2 times/year).
  • Regular and appropriate reporting relationship to GQ-QLP management.
  • Miscellaneous contacts as assigned by GQ-QLP management.


Knowledge and Skills:
  • University graduate (science degree preferred).
  • Sufficient specific technical knowledge of the areas subject to evaluation and audit as evidenced by working at least 2 years in the pharmaceutical industry or equivalent.
  • Good understanding of the drug development process; knowledge of regulations relevant to preclinical and/or clinical research.
  • Excellent oral and written communication and interpersonal relationship skills.
  • Strong critical thinking to analyze complex situations and discern critical issues.
  • Ability to manage competing priorities.
  • Commitment to Quality.
  • Computer literacy.
  • Sense of diplomacy and discretion.
  • Excellent team player attitude.
  • Ability to work effectively with multicultural workforce.


Behaviors Required:
  • Passion
  • Innovation
  • Accountability
  • Speed


Working Conditions:
  • Approximately 10 % travel, including overnight, may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
  • Overnight absences required (per typical month) :
  • Overnight travel may include one trip every two months with stays of up to four nights.
  • This position may require employee to come in contact with chemical or biological agents which may pose health or safety hazards if improperly handled