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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 .

Position Summary

The Director, Quality Governance will mainly be responsible for designing, developing, and implementing an effective Quality & Compliance Governance framework across nonclinical, clinical and pharmacovigilance functions that empowers decision-making through data-driven insights, cross-functional collaboration and continuous innovation. Ensuring that key highlights, areas of excellence, and risks are escalated to relevant governance bodies in a proportionate manner, with a focus on significant matters that impact the business.

Key Responsibilities

• Responsible to design, develop and implement an effective Q uality and C ompliance G over n ance framework across nonclinical, clinical and pharmacovigilance in partnership with RDQ Leadership Team, Global Quality , D rug D evelopment and Early Research .

• Lead the roll up of relevant R&D risks and insights for reporting to Global Quality Councils, Enterprise Risk Committees, and overall Global Quality Risk Management .

• Operationalize Enterprise QRM strategy in R&D together with the QRM experts across functional units .

• Drive the effective management of R&D Quality Councils across nonclinical, clinical and pharmacovigilance ( final accountability resides with GxP Quality Council Co-Chairs ) ensuring rigor in meeting, action, documentation and timely follow-up on actions and decisions .

• Partner with GCP, GVP and GLP Quality Council Co-Chairs and R&D Quality Leadership Team, to ensure continuous assessment, evaluation, and communication of strategic, compliance, quality and operational risks within R&D.

• Ensure alignment with regulatory requirements, industry standards, and best practices ( e.g. provide oversight to ensur e connectivity in the implementation of new reg ulations ) .

• Conduct comprehensive data analysis and interrogation of data to derive meaningful , actionable insights that support data-driven decision-making at Global GxP Quality Councils .

• Ensure that the right conversations occur at the appropriate levels with the relevant stakeholders, focusing on what matters most to the business.

• Partner with Global Quality - Predictive Quality to ensure quality metrics are aligned with organizational goals , regulatory requirements , and support development of tools and reports to drive inspection readiness.

• Partner with Global Quality - Product Quality Management to provide insights on quality , compliance and operational risks to products in clinical trials and post marketing.

• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities , as needed.

• Champion a Quality Mindset and ensure compliance with key ICH guidelines ( e.g. E8 , E6 , E9 , Q9 ) and other relevant regulatory requirements.

Other

• Drive continuous improvement initiatives to enhance quality processes and systems.

• Develop and deliver training programs to enhance quality awareness and competencies across the organization.

• Provide leadership, guidance, development and coaching for management of significant quality issues.

• Establish strong partnerships with business stakeholders.

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

• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.

• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.

• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline. Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.

• Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the organization .

• 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 QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance .

Knowledge, Skills, and Abilities

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

• 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 - HOCT and ICN. 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.

• 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 .

• Fosters a culture in which people continually work to improve services, and work processes .

#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: R1588947

Updated: 2025-01-26 01:44:36.899 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.