Job Details

Associate Director Audits and Inspections

Clinical Dev

icon-location-marker Shanghai - CN
Posted 78 days ago Full_time R1542883

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.

  • Perform GCP audits of clinical investigator sites and GxP audits of vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (is a Lead auditor for a wide range of audit types)
  • Acts as a strong technical resource/expert for several GCLP and/or R&D topics within CTQA. Function as Subject Matter Expert (SME) to internal customers, as well as to Chinese functional lines, RDQ, and stakeholders
  • Maintain regional Business Intelligence of GCLP regulatory requirements and industry standards by closely followings the rapidly changing Chinese Regulatory environment and assess the associated risks and associated processes
  • Act as an advisor and back-up for the RDQ Regional lead
  • Regional GCLP compliance expert on related matters for R&D management
  • Drives quality improvements with stakeholders
  • 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
  • Support/Manage local and major markets Health Authority (HA) inspections, as assigned
  • Represent CTQA on stakeholder initiatives or in a regional improvement or quality related initiatives
  • May influence the external environment through interactions with regulators, trade associations, or professional societies
  • Represent department on due diligence activities for vendors and business partners
  • Lead non-compliances and alleged cases of scientific misconduct investigations, as assigned
  • Called upon to resolve GxP issues and provide direction or strategy relative to technical expertise
  • Assesses and supports the implementation of emerging regulations based on areas of technical expertise
  • Able to function as a member of GCP Quality Council or equivalent/other
  • Support RDQ-CTQA in the hiring process of new staff and their integration through mentoring, as assigned

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.