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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 .

Key Responsibilities

CAPA management:

• Lead the development, implementation, and maintenance of a robust CAPA program to ensure effective root cause analysis, CAPA planning, and compliance with regulatory requirements and industry best practices.

• Responsible to deliver expert root cause analysis capabilities in support of significant quality issue investigations and action plans.

• Responsible for CAPA oversight, ensuring clear tracking and metrics to drive on time performance.

• Monitor and analyze trends to identify areas for improvement and aimed at driving effectiveness and simplification.

• Ensure rigor in conducting thorough investigations, root cause analysis, and developing effective corrective and preventive actions.

• Develop and deliver training programs to enhance the understanding and effectiveness of the CAPA process across the organization.

• Ensure effective communication and reporting of CAPA activities and outcomes to senior management and relevant stakeholders.

Serious Breach management:

• Enhance and streamline the serious breach reporting process to drive efficiency, eliminate waste, and facilitate clear, timely communication and trend analysis.

• Oversee the identification, documentation, and reporting of serious breaches in compliance with regulatory requirements and company policies, ensuring timely and accurate communication to relevant authorities and stakeholders.

• Lead cross-functional teams in the investigation and resolution of serious breaches, implementing corrective and preventive actions to mitigate risks and prevent recurrence.

• Monitor and analyze trends to identify potential risks and areas for improvement in a proactive manner.

Other:

• Line management responsibility to oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.

• Collaborate with cross-functional teams, including but not limited to GPOs and the Business Process Council, to ensure the timely and effective resolution of quality issues, and to share lessons learned and best practices.

• Foster a culture of quality and continuous improvement within the organization.

• External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

• Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.

• May influence the external environment through interactions with regulators, trade associations, or professional societies.

• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Qualifications & Experience

• 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 of GxP CAPA Management experience in Quality, Clinical Development or Regulatory Compliance.

Required Competencies: Knowledge, Skills, and Abilities

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

• Extensive experience in CAPA Management and Serious Breach reporting requirements.

• Very experienced in Nonclinical, Clinical and Pharmacovigilance processes.

• Good understanding of BMS's therapeutic areas - ICN and HOCT.

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

• Proven track record of leading and managing cross-functional teams.

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

• Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.

• Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

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

• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

• Ability to drive change and foster a culture of continuous improvement.

#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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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

Company: Bristol-Myers Squibb

Req Number: R1588951

Updated: 2025-01-26 01:44:36.955 UTC

Location: Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.