Senior Manager, R&D Quality Clinical Trials & Auditing QA

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.

Research and Development Quality- Clinical Trials Quality Assurance (RDQ-CTQA) is responsible for the quality governance and auditing of clinical trials and associated systems. RDQ-CTQA defines the Clinical Quality Management Systems (QMS) enabling strategies and technologies and coordinates Quality Risk management at the compound and process levels to inform the audit focus and drive implementation of Quality Risk Management. RDQ-CTQA audits all processes related to clinical research, including investigator site, country, process, vendor and partner audits, to assess compliance with relevant regulations and applicable policies and procedures. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. RDQ-CTQA also offers support as Subject Matter Expert during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job

The Senior Manager will work in the RDQ-CTQA group. This group conducts Good Clinical Practice (GCP) audits off clinical investigator sites, vendors, internal systems/processes; lead/collaborate on due diligences and pre-qualification audits. The senior manager will also act as an expert in specific GCP related areas and may support Health Authority Inspections as assigned.

Key Responsibilities and Major Duties

  • Perform GCP audits of clinical investigator sites, vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (may function as a lead auditor for wide range of audit types)
  • Act as an expert resource for a certain GCP topic within RDQ-CTQA and may function as SME (providing advice and counsel) for the concerned area for the development of SOPs (QA and stakeholder-based) and delivery of training to auditors in the area of expertise
  • Lead and/or participate into GPS and/or BMS company processes and improvement initiatives
  • Support other areas within RDQ in the creation and maintenance of project/study audit plans; prior to and post audits by sharing newly identified risks to be explored in future audits.
  • May assist/coordinate local and major markets HA inspections
  • Represent RDQ-CTQA position during internal meetings
  • Perform peer audit report review as required
  • Represent department on due diligence activities for vendors
  • Co-Investigate alleged cases of scientific misconduct or corporate compliance R&D related investigations as assigned

Supervisory Responsibility

Not Applicable

Key Stakeholders/Contacts

  • RDQ-CTQA Management; audits and inspections /Quality Solutions and CAPA
  • RDQ-Clinical Development and Operations QA and other functions within RDQ
  • (Co-) Auditors RDQ-CTQA
  • Internal stakeholders; e.g. technical, supervisory and management personnel
  • External stakeholders: e.g. vendors, investigator sites
  • External auditors and inspectors during the conduct of Health Authority inspections
  • Applicable company product development-, development operations- and regulatory department personnel, related to initiatives or processes for which the incumbent is involved as the lead or as the RDQ-CTQA Subject Matter Expert.

Minimum requirements:
  • Degree/Certification/Licensure
  • University Graduate, Life Sciences degree preferred.

Experience - Responsibility and minimum number of years

  • Demonstrated working knowledge of principles and concepts of QA including those related to QRM and Critical Thinking
  • GCP wide range of auditing skills including audits at vendors, systems supporting clinical trials as well as profound inspection coordination skills
  • Knowledge of ICH-GCP guidelines and working knowledge of GxP Guidelines/regulations.
  • Understanding of the drug development process and regulatory environment
  • Knowledge of other disciplines in stakeholder’s organizations to influence and support improvements in products, processes and services
  • Minimum of 4 years in clinical QA auditing and / or 6 years of work experience in clinical research and/or GCP related QA environment

Competencies - knowledge, skills, abilities, other
  • Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for GCP audit findings or issues consistent with company policy, regulatory references and business strategy.
  • Excellent oral and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
  • Excellent negotiation and influencing skills collaborate effectively with cross-functional team members
  • Spanish language fluency is a plus
  • Maintains the confidentiality and security of information, data, documents and records
  • Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues
  • Understands interdependencies
  • Escalate issues to appropriate people within department/organization
  • Demonstrates commitment to delivering high-quality work product
  • Able to function independently within an environment that relies heavily on technology for information and communication
  • Sense of diplomacy and discretion
  • Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment

Travel Required:

Approximately 25% travel to perform audits and attend professional meetings and seminars.

Overnight Absences:

Approximately 5 overnight absences per month.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.