Director, GDM Process Excellence Leader

2 weeks ago


Madison, New Jersey, United States Bristol-Myers Squibb Full time
Job Title: Director, GDM Process Excellence

Bristol-Myers Squibb is seeking a highly skilled and experienced Director, GDM Process Excellence to join our team. As a key member of our organization, you will be responsible for maintaining a robust Quality Management System (QMS) covering GDM business processes and quality events.

Key Responsibilities:
  • Set the strategic vision to ensure efficient, effective, and compliant working practices.
  • Establish appropriate structures and processes to execute the strategy.
  • Lead GDM Subject Matter Experts (SMEs) and relevant stakeholder functions in the development and maintenance of global processes, procedures, and training materials.
  • Provide guidance and direction to GDM SMEs to ensure the procedure development process, content, and format comply with Global GxP requirements, BMS Global Quality Standards, and BMS' QMS principles of integrated, patient-centric, and risk-based decision-making.
  • Collaborate with other Process Leads and SMEs to drive optimal execution of process across BMS and external partners.
  • Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product/clinical trial quality and process effectiveness aspects.
  • Lead efforts to scope, plan, and implement process improvements such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles.
  • Serve as the central point of contact for GDM regarding GxP audits and inspections, coordinating with GDM Leaders and SMEs on the preparation and subsequent follow-up activities.
  • Provide guidance to ensure effective corrective and preventative action plans are defined for any GDM related audit and inspection findings and actions plans are tracked to completion.
  • Provide training to GDM Leaders and staff regarding procedure development and CAPA definition to promote quality.
  • Collaborate with R&D Learning to define and maintain role-based procedure training curricula.
  • Ensure adaptive management of a global team through the effective deployment of resources and streamlined processes.
  • Provide ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empower and hold staff to high quality performance and delivery.
  • Engage and energize employees through communication of goals, priorities, and other business critical information as well as focus on employee value proposition, development, and retention activities.
  • Develop and promote a work place culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.
  • Lead the resolution of complex issues related to the function and those that cross functions. Direct team members as needed to drive to resolution and keep leadership informed of progress/results.
  • Develop strong and productive working relationships with key stakeholders throughout BMS, demonstrate the ability to think strategically across R&D, and effectively influence peers and senior management.
  • Represent the company with key external organizations as part of any committee or industry group relating to GxP/QMS, data quality & integrity activities.
Requirements:
  • Bachelor's degree required with an advanced degree preferred.
  • At least 10 years of relevant industry experience in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred.
  • Expert understanding of the drug development process and clinical trial execution.
  • Expert knowledge of industry trends and emerging technologies supporting clinical trial data acquisition and management.
  • Expert knowledge of GCP/ICH guidelines.
  • Proven track record of resolving complex issues and driving significant initiatives to completion.
  • Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients.
  • Proven track record in functioning within a global matrix organization exerting positive, effective influence to achieve quality outputs.
  • Demonstrated change agility in anticipating and leading others through change and ambiguity.
  • Demonstrated partnership across various collaborative and industry forums.
  • Demonstrated people management experience.

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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