Bristol-Myers Squibb Company

GQ-QLP Auditor

Location
New Brunswick, NJ, United States
Posted
Sep 18, 2019
Ref
R1517657
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

QLP: GQ Quality Laboratory Practices (QLP)serves as the GLP Quality Assurance Unit which inspects and audits each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of GQ-QLP as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections.

Principal Objective of the Position

This is an auditing position where knowledge and understanding of the regulatory framework, regulatory requirements, processes, systems and procedures matures. More independence is gained in evaluating preclinical operations against regulatory requirements, policies and procedures, identifying areas of noncompliance, and recommending appropriate remedial actions.

Key Responsibilities and Major Duties
  • Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research
  • Conduct Good Laboratory Practices audits and inspections of preclinical 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 study activities.


  • Prepare and submit written reports of these inspections to study director and management.
  • Audit final reports and raw data for these studies.
  • Perform Good Laboratory Practice systems audits at various BMS 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.
  • Prepare clearly written, 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 GQ-QLP audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required.
  • Assist in the preparation of departmental standard operating procedures.
  • Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies.
  • Provide assistance to other GQ-QLP personnel during inspections by regulatory agencies (e.g., FDA, USDA, etc.).
  • Conduct other audits or investigations of regulatory concern as directed by management (e.g., Animal Welfare Practices, Controlled Substances, etc.)
  • Adherence to BMS core behaviors

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Stakeholders/Contacts describe key internal matrix relationships and list key external stakeholders/clients
  • Daily collaboration with other GQ-QLP auditors in the preparation, conduct, reporting and follow up of audits and inspections. Relationships with other auditors should include sharing of knowledge and mentoring of less experienced auditors or associate auditors
  • Regular 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 the evaluation of these facilities
  • Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections
  • Regular and appropriate reporting relationship to GQ-QLP management.


Key Competencies - knowledge, skills, abilities, other
  • Basic knowledge of regulatory requirements for preclinical research
  • Effectively communicated verbally and in writing and able to impact and influence people
  • Computer literacy
  • Strong critical thinking to analyze complex situations and discern critical issues
  • Commitment to quality
  • Able to analyze and interpret complex problems/data gathered from a variety of sources
  • Able to meet high requirements within tight deadlines and adapt to changing priorities
  • Accountable for actions and results
  • Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
  • Good Judgement and sense of discretion


Travel Required (nature and frequency)

Approximately 10% travel 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.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.