Director, Development Quality

Bristol Myers Squibb•Devens, MA

9d•Hybrid

About The Position

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. 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 Director, Development Quality – NS will mainly be responsible for designing, developing, and implementing risk-based quality management strategies to identify, assess, and mitigate risks throughout the clinical trial process. This ensures compliance with regulatory requirements, maintains the reliability and interpretability of trial results, safeguards patient safety, and upholds the quality of study data.

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 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 Risk Based Quality Management principles.
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.

Responsibilities

Ensure Quality Strategies for NS portfolio are developed to avoid, detect and address serious non-compliance with GCP, the trial protocol and applicable regulatory requirements to prevent recurrence.
Oversee development of the Quality Narrative (or equivalent) at the ASSET / TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
Manage a team of Asset Quality Leads and oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.
Partner with the Drug Development organization to drive adoption of Quality by Design principles across BMS protocols to ensure quality is built into the scientific and operational design and conduct of clinical trials.
Ensure risks to critical to quality factors are managed prospectively and adjusted when new or unanticipated issues arise once the trial has begun.
Provide leadership, guidance, development and coaching to the R&D Risk Management team for management of significant quality issues.
Lead for-cause, critical and/or complex quality issues as well as serious breaches for the TA, if needed.
Provide R&D Quality expertise, critical thinking, and partner with Drug Development to deliver training and education (e.g., use cases, best practices, road shows, etc.) to support effective RBM practices.
Establish strong partnerships with business stakeholders and participate in GPT / CDT / other relevant governance committees for the ASSET. Preferably from ID-2 (Go to Development) or ID-3 (Go to POC).
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.
Define, own, and execute R&D Quality processes contributing to Drug Development’s end-to-end Risk Management framework across the clinical trial portfolio.
Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
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 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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume