Director, Therapeutic Area Quality Lead

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 rich in diversity. 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

The main responsibility of the Director, Therapeutic Area (TA) Quality Lead will be to create a Quality Strategy and oversight within the Oncology therapeutic area and deliver the full range of quality related activities to support.

Role Responsibilities:

• Design and implement the quality strategy for the Oncology Therapeutic Area

• Independently assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary

• Identify and drive continuous quality process improvements as a consequence of audits, assessments, inspections, trends/metrics and root cause analysis

• Drive implementation of Quality by Design principles

• Develop, implements and maintain the program quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities

• Integrate end –to end quality principles and review project milestones with R&ED/GDD

• Establish strong partnership with business stakeholder

• Deliver independent expert support and propose solutions

• Lead the presentation of key data (compliance, conformance, issues and risks) to drive decision making

• Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA

• Initiate appropriate activities to support product submissions

• Ensure successful Health Authority engagement

• Participate/provide expertise in in licensing activities as applicable

• Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners

Role Requirements:

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training and experience

• Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance

• Very experienced in nonclinical/clinical research/pharmacovigilance experience

• In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management

• Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)

• Extensive experience in regulatory inspection preparation, management, and related follow-up

• Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data

• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution

• Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.