Senior Compliance Auditor
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: Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.
Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, including Global Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel, monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed.
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; Collect information through effective interviewing, listening, observing and reviewing documents, records and data; Prioritize and focus on matters of significance; 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; Prepare clearly-written, concise, accurate and evidence-based audit report; Review and assess (or support the review) received 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.
Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.
Regularly evaluate clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.
May provide mentoring for new staff, as needed.
Regular collaboration/contact with GCO and GRSB personnel related to projects for which the incumbent is Project Coordinator.
Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of health authority inspections either at clinical sites or at BMS facilities.
Miscellaneous contacts as assigned by R&D quality -CT&S management.
Supervisory Responsibility: None Key Stakeholders/Contacts: Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located 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: o Bachelor's degree required - Life Sciences degree preferred Experience/Responsibility and minimum # of years: o Solid previous experience in clinical trial related roles o Demonstrated specific technical knowledge of the GCP areas subject to audit, as evidenced by at Ieast 4 years in the pharmaceutical industry preferably in the R&D/clinical trial or equivalent area.
o Desired minimum 2 years of auditing (GCP auditing is preferred) Competencies/Knowledge/skills o Strong skill in risk based prioritization o Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions; o Good understanding of the drug development process o Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication o Excellent oral and written communication; o Fluent in English (and other languages, as applicable to assigned audit region); o Sense of diplomacy and discretion; o Maintains the confidentiality and security of information, data and records; o Demonstrates commitment to delivering high-quality work product; o Knowledge of governmental regulations impacting clinical research and drug development o Understand the appropriateness and consequences of using sampling techniques o for auditing; o Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; o Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment; o Develops strong working relationships with key stakeholders; o Ability to manage competing priorities.
BMS Behaviors and Working conditions : o BMS Biopharma Behaviors required: Passion, Accountability, Innovation,Speed o Travel Required (nature and frequency) approximately 25% travel to perform audits and attend professional meetings and seminars.
o Overnight Absences Required (per typical month): Approximately 5 days per month o Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )
Associated topics: business, company, compliance office, corporate attorney, counsel, court, legal affairs, legal department, llp, market