Bristol-Myers Squibb Company

Associate Director - Global Quality Clinical Trials and Safety

Princeton, NJ, United States
Feb 25, 2019
Required Education
Bachelors Degree
Position Type
Full time
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 GQ - CT&S leadership as informed.

• Represent GQ-CT&S as an expert in specific GCP/PV related areas

Key Responsibilities and Major Duties

• Within multiple areas of GCP/PV expertise, act as an expert resource;trainer for GQ-CT&S and as liaison with key stakeholders to provide input into related audit strategy and plans

• Within areas of expertise, maintain awareness of trends and new developments internally and externally

• 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;

• Maintain audit database

• 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.

• Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.

• Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.

• May provide mentoring for new GQ-CT&S staff, as needed.

• Support upper management on the on-boarding of new hires

• Represent GQ-CT&S position during internal and external meetings

• Lead project related teams or workstreams as assigned

• Act as an advisor and back up to the Director

• Coordinate health authority inspections as assigned and maintain inspection tools repository

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.

• Regular collaboration with GQ-CT&S colleagues and with GCO and GRSB personnel

• 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 GQ-CT&S management

List of minimum requirements

o Degree/Certification/Licensure

o Bachelor's degree required - Life Sciences degree preferred

o Experience/Responsibility and minimum # of years:

o Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at Ieast 8 years in the pharmaceutical industry

o Minimum 5 years technical auditing and/or related experience; PV and GCP auditing preferred

o 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 Excellent understanding of the drug development process and end to end quality process

o Support GQ-CT&S management on identification of areas to increase department efficiency

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 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.

o Ability to lead change process within functional group

o Possesses detailed knowledge of areas of expertise and could teach or mentor others

o Develops and applies new methods and ideas to enhance performance

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

Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc