Associate Director GQ CTS Audits and Inspections - Bristol Myers Squibb - Braine-l'Alleud

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.

• Act as an expert resource/trainer for GQ-CT&S;
• Lead GPS and/or BMS company process- and improvement initiatives;
• Perform GCP and 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 an advisor and back-up to the Director of GQ-CT&S.

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.