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 Clinical Supply Operations (CSO) organization is accountable for the execution of investigational drug product manufacturing, packaging & labeling, and associated planning & operations activities. This position plays a key role in advancing the organizations Culture of Excellence efforts by managing CSOs compliance activities such as administration of the quality risk management program, data integrity program, and audit / inspection coordination and management. The position also oversees CSOs alignment with an optimized Quality Management System (QMS) and other quality and compliance related initiatives, and is accountable for working with quality and functional areas to identify and implement opportunities for improvement as they relate to quality systems and compliance.

Responsibilities:

Working with Product Development Quality (PDQ) to administer and improve the implementation of the quality risk management program within CSO and ensure alignment with global procedural requirements

Partnering with PDQ to manage the CSO implementation of quality programs / initiatives and regulatory updates, including but not limited to the following ongoing programs:

* Data Integrity
* Investigation Excellence
* QMS optimization implementation

Serving as CSO point of contact for coordination of self inspections, internal audits and health authority inspections. Identifies efficient processes for audit & inspection management and readiness. Works with functional areas to ensure observations and CAPA responses are assessed for impact throughout the all CSO functional areas.

Interfacing with PDQ, PD Operations Learning & Compliance, and CSO functional areas to identify, implement, and sustain opportunities for improvement as it relates to quality system administration and compliance

This individual will also become a qualified lead investigator and risk management facilitator and will provide technical support for complex and/or cross functional risk facilitation and deviation management, as required

Qualifications:

* Strong working knowledge of GMP regulations and industry best practices
* Demonstrated success leading in a matrixed environment
* Strong verbal and written communication skills, with the ability to engage with multiple stakeholder groups

Ideal Candidates Would Also Have:

* A combination of both commercial and clinical/phase appropriate quality systems experience
* Experience implementing data integrity controls

Other Qualifications:

* Undergraduate/graduate degree in a technical field
* 5-7 years relevant pharmaceutical industry experience

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.