Bristol-Myers Squibb Company

Compliance Auditor - Global Quality -Clinical Trials and Safety

Location
Princeton, NJ, US
Posted
Apr 12, 2018
Ref
R1504045
Required Education
Doctorate/PHD/MD
Position Type
Full time
Description of the area:

Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is also responsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GVP) requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job:

To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.

Key Responsibilities and Major Duties:
  • Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;
  • Apply audit principles, procedures, and methods; Prioritize and focus on matters of significance;
  • Collect information through effective interviewing, listening, observing and reviewing documents, records and data;
  • Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
  • Assess those factors that may affect the reliability of the audit findings and conclusions; Perform and document analyses of audit findings where indicated;
  • Prepare clearly-written, concise, accurate and evidence-based audit report;
  • Maintain audit database;
  • Support management on review of efficiency indicators of the auditing group (through review of audit databases, metrics to generate audit reports)
  • Schedule audits with sites and vendors as applicable for the group
  • such as Ensure audit database is updated for all audits and
  • Review and assess (or support the review) corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence;
  • Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines;
  • Provide advice and counsel concerning GCP regulatory requirements.
  • Create and/or review metrics and trend analyses on audit and inspection findings


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

Supervisory Responsibility:

None.

Key Stakeholders/Contacts:

Regular contact with GQ-CT&S management, strategy roles, GQ and clinical quality governance group (risk management and CAPA), colleagues/co-auditors globally.

Contact with appropriate technical, supervisory and management personnel internally and externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.

List of Minimum requirements:

Degree/Certification/Licensure:

University Graduate, Life Sciences degree preferred

Experience - Responsibility and minimum number of years:

Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at least 2 years+ in the pharmaceutical industry (preferably in the R&D clinical trial or equivalent area)

Competencies - knowledge, skills, abilities, other
  • Skilled in risk based prioritization
  • Strong data analytical skill
  • Critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
  • Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication
  • Good understanding of the drug development process;
  • Good oral and written communication; Fluent in English and other languages, as applicable to assigned audit region;
  • Sense of diplomacy and discretion;
  • Maintains the confidentiality and security of information, data, documents and records;
  • Demonstrates commitment to delivering high-quality work product;
  • Knowledge of governmental regulations impacting clinical research and drug development
  • Ability to
  • Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
  • Develops strong working relationships with key stakeholders


BMS Behaviors and working conditions:
  • BMS Biopharma Behaviors required: Passion, Accountability, Innovation, Speed
  • Travel Required (nature and frequency) approximately 25% travel to perform audits and attend professional meetings and seminars.
  • Overnight Absences Required (per typical month): Approximately 5 days per month
  • Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )