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.
Description of the area:
Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research includingspecific medical affairs processes, and pharmacovigilance activities, to assess compliancewith relevant regulations and applicable policies and procedures. This includesinvestigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is alsoresponsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GPV) 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 described above.
Act as project-specific liaison between Global Quality - CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to plan audits and assuring Global Quality - CT&S leadership is informed.
Key Responsibilities and Major Duties
Perform GCP and PV audits, including audits of clinical investigator sites, vendors (including laboratories under GCLP), internalsystems and clinical study reports to assess regulatory compliance;
Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewingdocuments, records and data;
Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findingsand conclusions;
Assess those factors that may affect the reliability of the audit findings and conclusions;
Prepare clearly-written, concise, accurate and evidence-based audit reports;
Review and assess (or support the review) received corrective and preventive action plans according to specifiedtimelines to ensure resolution of audit findings and prevent recurrence.
Maintain an in-depth knowledge of governmental regulations impacting clinical research, companion clinical devices, 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 stakeholders
Regularly evaluate clinical research processes to determine compliance withregulatory requirements and established standard operating procedures.
May provide mentoring for new staff, as needed.
Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of healthauthority inspections either at clinical sites or at BMS facilities.
Contacts with different stakeholders in several functional areas supporting drug development as assigned by Global Quality -CT&S management.
Key Stakeholders/Contacts -
Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), GQ GCLP (Global Clinical Laboratory Practices), GQ IT, colleagues/co-auditors located globally;
Contact with appropriate technical, supervisory and management personnel internallyand externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.
List of minimum requirements
Bachelor's degree in Life Sciences required
Experience/Responsibility and minimum # of years:
Solid previous experience in clinical trial related roles
Demonstrated specifictechnical knowledge of the GCP and GCLP areas subject to audit, as evidenced by atIeast 4 years in the pharmaceutical industrypreferably in the R&D/clinical trial, GCLP, CAP/CLIA certified laboratory or equivalent area.
Desired minimum 2 years of auditing (GCP auditing is preferred)
Preferred candidate would have laboratory experience, including assay development and validation, working knowledge of computer systems related to sample accessioning, analyses, and reporting, as well as equipment IQ/OQ/PQ and PM processes. Experience auditing laboratories under GLP or GMP are a plus. Ideal candidate would additionally possess auditing genetic laboratory experience.
Preferred candidate would have experience assessing the quality of CDx IVD vendors.
Strong skills in risk based prioritization and multi-tasking
Strong critical thinking to analyze complexsituations and discern critical issues andnon-compliant situations and torecommend appropriate corrective and preventive actions;
Good understanding of the drugdevelopment process
Knowledge of regulations governing clinical diagnostic laboratories (e.g CAP/CLIA)
Strong understanding of CDx IVD vendors quality aspects
Demonstrates computer literacy and is ableto function independently within an environment that relied heavily on technology for information and communication
Excellent oral and written communication;
Fluent in English (and other languages, asapplicable to assigned audit region);
Sense of diplomacy and discretion;
Maintains the confidentiality and securityof information, data and records;
Demonstrates commitment to deliveringhigh-quality work product;
Knowledge of governmental regulations impacting clinical research and drug development
Understand the appropriateness andconsequences of using sampling techniques
Ability to make ethical, scientifically soundrecommendations, consistent with company policy/strategy and cost effective;
Demonstrates flexibility, open-mindednessand adaptability to a rapidly changing environment;
Develops strong working relationships withkey stakeholders;
Travel Required (nature and frequency) approximately 25% travel to perform auditsand attend professional meetings andseminars.
Overnight Absences Required (pertypical month): Approximately 5 days per month
Software that must be usedindependently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Infinity (in Veeva Vault), SharePoint, etc )
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.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.