Director, ExM Quality Biologics Drug Substance

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.

Manage the Quality of the Biologics Drug Substance External Manufacturing operations team. Assures that quality and compliance standards are achieved in the Drug Substance ExM operations. Working as a key member of the Virtual Plant Team and as part of the ExM Extended Leadership is responsible to identify and address any compliance and quality issues to ensure that quality product is available for our patients. Provides leadership and is accountable for all quality and compliance issues for the assigned CMOs.

Responsibilities:

• Manage a team of associates in collaboration with the Virtual Plant teams to ensure quality, reliable and effective supply of the products within CMO scope through collaboration and innovation.
• As a member of the Extended Quality ExM Leadership team support the development of the External Manufacturing Strategy and drive the execution of the Strategy.
• Partners with MS&T and other SMEs to oversee and provide required support to our CMOs and internal stakeholders.
• Provides resources and guidance to ensure that oversight of CMOs is aligned with the BMS standards.
• Ensures that product released to the market is in compliance with the HA submissions and cGMP.
• Responsible of ensuring Change Controls, Investigations, Deviations, Customer Complaints, CAPAs, and other related documentation related to CMOs is managed in a compliant and timely manner.
• Provides support for BMS audit teams through team participation and liasing with CMO for requests.
• Responsible for product batch record review and disposition for assigned commercial products.
• Promotes team and leadership development, fosters teamwork, and builds relationship by coaching, providing continuous feedback.

Required Competencies

• 10+ years experience in the Sterile / Bio-pharmaceutical industry preferred.
• Bachelor's or advanced degree (e.g. Masters, PhD) in engineering, chemistry, pharmacy or related sciences.
• Strong background and demonstrated experience in Quality/Compliance decision making.
• Demonstrated experience in successfully managing pharmaceutical contract manufacturing preferred.
• Experience in managing multidisciplinary teams and/or directing major initiatives requiring the mobilization of cross-functional resources.
• Strong experience in implementation of new product launches in order to understand time and events schedules, investments and product cost.
• Experience in managing internal/external environments, such as effective communications within and outside the organization.
• Experience in development and management of P&L including budget preparations and financial reporting.
• Knowledge of financial concepts such as P&L, budgeting and other financial processes.
• Enhance the ability to work and manage in a complex matrix organization.

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.