Senior Director, Competitive Compliance (Corporate Quality)

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Position Summary

Reporting to the Vice President, Corporate Quality, this role provides strategic and tactical direction for the GPS divisional audit program for product development, clinical supplies, manufacturing, and product distribution across all modalities including CMOs, CLOs, material suppliers and service providers, inclusive of IT systems and services. Leads inspectional readiness activities across the network inclusive of biologics, small molecule and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. Serves as consultancy to sites/functions with regulatory inspections including Pre-inspection readiness.

Key Responsibilities

·       Responsible for development of risk-based process for assessment of sites, suppliers and contract providers across all modalities and vendor types ensuring inspection readiness strategies and risk mitigation across the enterprise.

·       Responsible for the execution of strategic audit plan and identification of emerging risk.

·       Development of Inspection Readiness strategy that provides standardized end-to-end approach to inspection preparedness that can be leveraged by the BMS network.

·       Collaborate to Identify emerging internal and external compliance indicators to proactively inform inspection readiness strategy. 

·       Partners with business to accommodate ad-hoc audits based on performance or changes in business needs.

·       Responsible for management of risk-based audit program across all modalities and vendor types.

·       Partners with business units and functions to drive remediations of audit outcomes with a lens towards enterprise performance and patient supply.

·       Serves as consultancy to sites/functions with regulatory inspections including pre-inspection readiness as well as regulatory inspection responses for complex compliance matters.

·       Assist with regulatory notifications, including assuring appropriate and consistent standards are in place

·       Works closely with legal to ensure robust and appropriate communications with external regulators globally.

·       Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.

·       Continuous improvement across R&D and GPS quality metrics defined by GxP requirements.

Qualifications & Experience

·       Minimum of a bachelor’s degree in scientific discipline.

·       15 plus years’ experience in the pharmaceutical industry.

·       Thorough understanding of regulatory require