Job Description

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 Director, Regional Clinical Compliance, Americas will be placed within the Global Clinical Compliance & Continuous Improvement function of Global Development Operations (GDO). This role will report to the Executive Director, Clinical Compliance and Risk Management Head.
This role will support and enable corporate GDO objectives through support of implementation of the GDO audit management plan, preparing and providing local on-site local health authority inspection support assuring GDO is always inspection ready.

The role will interact with the global quality function in support of any sponsor inspections and activities in any of the local markets. There will be a significant partnership with the Global Quality organization.
This role will lead a team of GDO employees who have demonstrated and core expertise in Good Clinical Practice (GCP), ICH and Health Authority expertise who are focused on in support of the regional business activities primarily site relations, field CRAs and health authority interactions as needed.

Responsibilities
•    Collaborate with key stakeholders to develop and implement a process for management of quality issues
•    Engage stakeholders to utilize processes and technologies in support of QMS processes
•    Embed a sustainable GDO Quality Culture & execute the GDO related QMS
•    Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate
•    Identify trends to enhance training and process improvements, assurance that findings from the Accompanied Monitoring Program are tracked and acted upon as part of a wider QMS
•    Oversee vendor activities in relation to monitoring activities in accordance with the Accompanied Monitoring Program
•    Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities
•    Identify and support the development & implementation of technical training across GDO and within the respective region
•    Assure inspection readiness within the respective region through implementation of the GDO audit management plan, on-site support during site Health Authority inspections and/or local sponsor Health Authority inspections in partnership with BMS global quality organization
•    Coordinate local health authority site inspections or sponsor inspections as necessary

Qualifications 
•    A minimum of 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 
Travel Required
•    Up to 50% domestic and international travel may be required.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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