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Job Details


Bristol-Meyers Squibb, Co.

Senior Director, Therapeutic Area Quality

Pharmaceuticals

All

Full Time

On Site

No

Princeton, New Jersey, United States

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.

Position Purpose

The Senior Director, Therapeutic Area Quality will…

  • Lead and inspire a strong, confident and diverse team of quality professionals
  • Ensure end to end data driven quality is designed into programs across all Therapeutic Areas
  • Demonstration of implementation of Quality Strategy and Quality Narratives to Health authorities
  • Define quality activities to ensure successful submission of our products
  • Deliver independent expert support to Clinical Development Stakeholders

Key Responsibilities

  • Design and implement quality strategy across all Therapeutic Areas (Oncology, Hematology, Cell Therapy, Cardiovascular, Immunology and Fibrosis)
  • Integrate end to end quality principles and ensure pro active quality is designed into projects and processes across all Therapeutic Areas
  • Supports the management Serious Breach process across TAs
  • Deliver independent expert support to Clinical Development and cross functional partners and creates strong partnership with stakeholders
  • Participate/provide expertise in Due Diligence activities as applicable
  • Ensure successful Health Authority engagement across TAs

Talent Development/Management

  • Create an environment that attracts, develops and retain high-quality employees
  • Engage and energize employees through communication of goals, priorities, as well as recognizing and celebrating success and achievements
  • Attract high-caliber talent and facilitate functional talent development through coaching to promote individual and team development
  • Promote a high-performance, externally-focused operating culture throughout organization which emphasizes customer, teamwork, personal accountability, and commitment to quality
  • Model desired behaviors personally and reinforce desired behaviors at all levels in organization

Other

  • Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
  • Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or cross-lines
  • Provide input in the global audit plans based on identified signals/trends/risks/gaps
  • May influence the external environment through interactions with regulators, trade associations, or professional societies
  • Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs
  • Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems

Key Stakeholders

  • Interaction with senior leadership in Global Clinical Development, Regulatory and Medical to influence decisions impacting quality and compliance
  • External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors and licensing partners as well as pharmaceutical company peers
  • Internal engagement as needed with relevant RDQ, R&D partners and corporate functions

Experience and Education

  • B.S. and/or M.S. in Chemistry, Biology, or Health related field
  • 12 plus years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
  • Previous senior management role with proven accountability and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

Key Competencies

  • Demonstrated strong knowledge of ICH/GCP, regulatory guidelines, clinical research processes and principles of Quality Assurance
  • Demonstrated ability to work in an international environment leading global quality functions
  • Exhibits strong leadership and management qualities including functional and cross functional team building, strong credibility and conflict resolution
  • Understanding of BMS’s Therapeutic areas
  • Exemplary leadership / influencing skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
  • Expert understanding of the overall audit process including design, and translation of findings into CAPAs that mitigate risks
  • Extensive experience in regulatory inspection preparation, management, and related follow-up
  • Demonstrated analytical and conceptual capability—including capacity to develop/translate long-range strategic plans into short-range operational goals
  • Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
  • Proficient at creating and communicating a clear vision among team members and effectively aligning resources/activities to achieve organizational goals
  • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
  • Delegates effectively, pushing responsibilities down to the appropriate level and focusing own time on high priority, strategic issues
  • Fosters a culture in which people continually work to improve processes

Software

  • Microsoft Suite, Trackwise CAT, SharePoint, Veeva

Travel and Overnight Absences

  • Once per quarter to attend professional meetings and seminars

#LI-Hybrid

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 recognises 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to [Register to View] Applicants can request an approval of an adjustment prior to accepting a job offer.

Bristol Myers Squibb is Disability Confident – Committed

A UK Government scheme