Associate Director-Global Quality-Clinical Trials and Systems Auditing QA

Main Location
New York City, NY, United States
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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Global Quality (GQ) – Clinical Trials and Systems Auditing QA GQ-CT&S QA is responsible for the quality governance and auditing of clinical trials to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal processes and systems (e.g. clinical monitoring) supporting the clinical trials, and external clinical trial related vendor audits. Our department is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. GQ-CT&S also offers support as SME during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job

The Associate Director will work in the GQ CT&S group. This group audits all processes related to clinical research and reports to the regional/ line management within GQ-CT&S under the structure of an end-to-end Global R&D Quality organization. The key objectives of this position are:  

  • To conduct Good Clinical Practice (GCP) audits as above described and support Pharmacovigilance (PV) Audits as required
  • To coordinate and/or support health Authority GCP inspections as assigned
  • To act as an expert in specific GCP-related areas.
  • To manage the regional audit planning as assigned
  • To supervise audit staff, as assigned

Key Responsibilities and Major Duties
  • Directly supervise audit staff  (as assigned) including responsibility for providing ongoing guidance, development and performance assessment and/or manage a local audit function as assigned;
  • Act as an expert resource/trainer for GQ-CT&S;
  • Lead GPS and/or BMS company process- and improvement initiatives;
  • Perform GCP and support PV audits, including audits of clinical investigator sites, vendors and internal systems to assess regulatory compliance;
  • Represent GQ-CT&S on Due Diligence activities for vendors
  • Lead or co-lead compliance Investigations, as assigned;
  • 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;
  • Prepare clearly-written, concise, accurate and evidence-based audit report;
  • Maintain audit database;
  • Review and assess 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 research and development of medicines
  • Provide advice and counsel concerning GCP regulatory requirements;
  • Support the Quality Governance and Risk Assessment team in the creation and maintenance of project study plans while preparing for and after audit conduct of investigator site audits;
  • To manage the regional audit planning, as assigned;
  • During audits, evaluate key GCP processes to determine compliance with regulatory requirements and established standard operating procedures;
  • Coordinate key, high risk HA inspections, as assigned.
  • Provide mentoring for new GQ-CT&S staff, as assigned;
  • Represent GQ-CT&S position during internal and external meetings;
  • Act as a liaison with key stakeholders and provide input into related audit strategy and plans, GPS and /or BMS company processes; e.g. PEARL team member or specific initiatives;
  • Act as an advisor and back-up to the Director of GQ-CT&S.

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

Supervisory Responsibility

May supervise audit staff, where indicated

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 Global Clinical Operations, Regulatory, Statistics and other functions’ personnel
  • Possible interactions with external auditors and Health Authority 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
  • Degree/Certification/Licensure
    • University / Bachelor’s Degree – Life Sciences degree preferred

  • Experience/Responsibility and minimum # of years:
    • Demonstrated expertise and specific technical knowledge of the GCP areas subject to audit, as evidenced by at Ieast 8 years in the pharmaceutical industry 
    • Minimum 5 years technical auditing and/or related audit or inspection management experience;  GCP auditing preferred

  • Competencies/Knowledge/skills
  • Strong skill in risk based prioritization
  • Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
  • Ability to participate in the critical evaluation of quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations;
  • Profound knowledge of quality risk management. Ability to identify and escalate areas of high risk;
  • Ability to analyze complex situations, and to draw meaningful conclusions, by distinguishing the details from the essence of the issue;
  • Ability to discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions
  • Excellent understanding of the drug development process;
  • Demonstrates computer literacy and is able to function independently within an environment that relies heavily on technology for information and communication;
  • Excellent oral and written communication;
  • Fluent in English (and other languages, as applicable); Ability to adapt communication style to suit different audiences/cultures. Deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients;
  • Sense of diplomacy and discretion;
  • Maintains the confidentiality and security of information, data, documents and records;
  • Demonstrates commitment to delivering high-quality work product;
  • Profound knowledge of regulatory requirements/governmental regulations for clinical research and drug development;
  • Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management, during the audit, inspection or process improvement process;
  • Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;
  • Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment
  • Develops strong working relationships with key stakeholders.
  • Ability to manage competing priorities;
  • Ability to lead change processes within functional group
  • Possesses detailed knowledge of areas of expertise and could teach or mentor others;
  • Develops and applies new methods and ideas to enhance performance

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 and QMS system by Veeva Vault, Oracle clinical database, Medidata RAVE, Trackwise, Sharepoint, etc )

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Mission
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Associate Director-Global Quality-Clinical Trials and Systems Auditing QA
Bristol Myers Squibb