Bristol Myers Squibb Director, Quality Clinical Compliance and Risk Management in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The role Director, Quality Clinical Compliance and Risk Management will be placed within the Global Clinical Compliance & Continuous Improvement function of Global Clinical Operations (GCO). This role will support and enable corporate R&D objectives through support of the development and execution of CAPAs for issues identified outside of audit or during health authority inspections across the global R&D space by partnering with relevant operations and quality business partners. Under the management of the Head of Global Clinical Compliance & Continuous Improvement, this person is responsible to manage oversight strategies and programs related to quality issue management, to ensure that quality issues and events identified are robustly investigated, corrected and documented in the BMS Corrective and Preventative Actions (CAPA) management system as well as escalated to senior management when appropriate. They will also support ongoing trending of quality issues to drive robust CAPA activities.
The role will be responsible for supporting quality by design principled through development of the Risk Assessment and Categorization Tool (RACT) for study and program level risk in conjunction with the clinical trial teams.
The role will be responsible for the vendor oversight plan and any associated due diligence with those providers.
This role will lead a team of GCO employees who have demonstrated and core expertise in Good Clinical Practice (GCP), ICH and Health Authority expertise who are focused on development & implementation of the CAPA, implementation of the audit management plan and development of the RACT. This team will also work with Global Procurement & Clinical Trial Planning & Alliance Management to assure a comprehensive vendor management oversight plan and due diligence activities.
Collaborate with key stakeholders to develop and implement a process for management of quality issues
Own issue identification and escalation processes.
Drive identification of root cause analysis, mitigation and CAPA implementation with a view to understand & address effectiveness
Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate
Development of the BMS CAPA and driving the GCO audit management plan
Assure the development and maintenance of a BMS audit tracking system for the generation of periodic and ad hoc status reports on quality issues and events for trending and report out in BMS Quality System Management Reviews
Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities
Drive risk quality management process for GCO at the protocol, country, vendor and GCO process level, build models to identify potential issues
Support the development of the RACT in conjunction with the clinical trial teams, program teams
Development of the vendor quality oversight plan for GCO and take a role in any due diligence activities associated with business partnerships. Assess vendor capabilities to meet BMS quality standards and requirements. Oversee vendor performance in relation to these critical business expectations
A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred.
At least 8 years of experience in a GxP regulated discipline is required.
Knowledge of the global drug development process is required.
Experience in a GxP quality role is required and experience in clinical operations is preferred.
Experience in and/or knowledge of risk management in a regulated industry is required.
Ability to operate in a matrix organization is preferred
Up to 25% domestic and international travel may be required.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.