Senior Director Therapeutic Area Quality

Profile

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.

Purpose/Objective of the job

Key responsibilities of the Senior Director, Therapeutic Area Quality include: 1) Lead and provide end-to-end quality strategy all TAs; 2) Ensure quality is designed into projects and programs across TAs 3) Demonstration of implementation of quality strategy to Health authorities; 4) Define quality activities to ensure submission and inspection readiness; 5) Deliver independent experts support to Clinical Development Stakeholders; and 6) managing the serious breach process across TAs.

Research and Development Quality is responsible for the following:


Design and implement quality strategy across all Therapeutic Areas (Oncology, Hematology, Cell Therapy, Cardiovascular, and Immunology and Fibrosis)
Integrate end to end quality principles and ensure quality is designed into projects and processes across all Therapeutic Areas
Manage Serious Breach process across TAs and chair the Serious Breach Committee
Define quality activities to enable submission and inspection readiness
Deliver independent expert support to Clinical Development partners and ensure strong partnership with business stakeholders
Participate/provide expertise in Due Diligence (e.g. in-lincensing) activities as applicable
Ensure successful Health Authority engagement across TAs
Assess quality risks across the TAs and define activities that need to be conducted to mitigate the risks
Identify and drive continuous quality process improvements as a consequence of audits, inspections, trends/metrics and root cause analysis
Provide guidance and training on relevant GxP regulations and guidelines to cross functional business partners.


Supervisory Responsibility:

Director/Associate Director/Senior Manager Therapeutic Area Quality (directly 5 - 10)

Key Responsibilities and Major Duties


Design and implement quality strategy across all Therapeutic Areas (Oncology, Hematology, Cell Therapy, Cardiovascular, and Immunology and Fibrosis)
Integrate end to end quality principles and ensure quality is designed into projects and processes across all Therapeutic Areas
Manage Serious Breach process across TAs and chair the Serious Breach Committee
Define quality activities to enable submission and inspection readiness
Deliver independent expert support to Clinical Development partners and ensure strong partnership with business stakeholders
Participate/provide expertise in Due Diligence (e.g. in-lincensing) activities as applicable
Ensure successful Health Authority engagement across TAs
Assess quality risks across the TAs and define activities that need to be conducted to mitigate the risks
Identify and drive continuous quality process improvements as a consequence of audits, inspections, trends/metrics and root cause analysis
Provide guidance and training on relevant GxP regulations and guidelines to cross functional business partners.


Talent Development/Management


Create an environment that attracts, develops and retain high-quality employees
Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements
Attract high-caliber talent and facilitate functional talent development through coaching and provision of challenging assignments 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
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 cross-lines
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
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/Contacts


Interaction with senior leadership in Global Clinical operations, Pharmacovigilance and Epidemiology, Regulatory and Global Development and Medical to influence decisions impacting quality and compliance related to audits and inspections
Interactions with external auditors from partner companies and health authority inspectors during the conduct of health authority inspections
Contact with appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners etc.) in the conduct and reporting of audits
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 R&D partners and corporate functions


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 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.

Company: Bristol-Myers Squibb

Req Number: R1527017_EN

Updated: 2020-07-01 00:00:00.000 UTC

Location: Princeton,New Jersey

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.

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