Sr. Manager, GCP Root Cause Investigator

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. The Clinical Root Cause Analysis (RCA) Lead supports Bristol Myers Squibb Quality Objectives by leading Clinical RCA Investigations in the GCP area and offers the opportunity to resolve complex problems while meeting quality and timeliness requirements. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will be required to deliver on appropriate objectives and priorities, overcome obstacles, and deliver results within established timelines. Responsibilities Serves as a CAPA lead investigator, conducts and manages RCA, and performs impact assessments of GCP deviations Liaises with many different groups/organizations in the GCP area as a Lead Investigator Proactively identifies and facilitates resolution of obstacles to timely completion Leads and participates in cross-functional investigation teams Presents investigation findings to key stakeholders within Global Drug Development (GDD) Provides input into continuous improvement opportunities Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, to drive continuous improvement, and to streamline processes Contributes to trend analysis and metric tracking via critical thinking and quantitative analysis Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Builds effective teams committed to organizational goals; fosters inclusion and collaboration among teams to address relevant issues. Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality. Recognize Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one’s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches. Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility. Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses. Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways. Requirements BS in life sciences 6+ years GCP clinical trial management experience in pharmaceutical industry (sponsor or CRO), MS preferred Project Management and Lean Sigma training is strongly preferred. Solid understanding of ICH-GCP and Clinical Operations Drive for Results: Drives for results and success; conveys sense of urgency and drives issues to closure; persists despite any obstacles Demonstrated problem solving ability and quality mindset Good interpersonal, oral and written technical communication skills are essential. Ability to work in a highly matrixed and complex environment Demonstrated project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required Experience in leading Clinical investigations utilizing formal Root Cause Analysis tools is preferred (or the ability to obtain formal RCA training) Experience using data analytics (i.e. control charts, histograms, box plots) Extensive experience with SOPs, GCP and the know how to work within a regulatory environment required Prior experience facilitating/participating in Risk Assessments preferred 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.