Bristol-Myers Squibb Company

Director, Global Investigations and Investigations Global Process Owner

Location
New Brunswick, NJ, United States
Posted
Oct 10, 2019
Ref
R1518127
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Director of the Global Investigations will also oversee and lead cross-functional and cross-site investigations as deemed appropriate as it pertains to GxPs.

The Global Investigations GPO has ultimate accountability for the effectiveness and efficiency of the assigned process including ensuring appropriate process interdependencies with other systems and processes are defined and effective. In addition, this role will provide oversight for the management of all changes being planned and executed in the Investigations system.

Major Duties and Responsibilities
  • Accountable for the effective and efficient execution of the process as well as ensure full compliance with all internal and external regulatory requirements
  • Accountable to ensure process optimization, improvement and long term sustainability following standard methodology
  • Align resources to drive process optimization for function and assure key accountability
  • Ensure role definition and clarity on key accountabilities for process steps through an enterprise lens
  • Lead and assure alignment of GxP document practices across the enterprise
  • Endorse defined optimization metrics to ensure Quality outcomes and monitor performance for associated process (es).
  • Champion for an Enterprise-wide Quality mindset / Culture of Quality
  • Accountable for Global regulatory inquiries related to the process
  • Provide strategic leadership for establishing and maintaining a robust compliant investigation program across the end-to-end product lifecycle (GPS and R&D) and across all BMS sites and internal and external functions in alignment with relevant governmental regulations and guidelines
  • Provide oversight for the governance, management and coordination of activities related to the Global Investigation Program
  • Develop and maintain global processes, procedural document, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards, and BMS' Quality Management System (QMS) principles of integrated, patient-centric, and risk-based decision-making
  • Develop global processes with close cooperation and input from relevant functions and site/country leads
  • Develop, define and maintain Community of Practice (COP), including roles, operating mechanisms, communication strategies, and levels of training and access
  • Engage with Quality Leadership Team, GPS Leadership and other functional leaders to identify and empower COP members
  • Provide leadership, coaching, and training for PLs and COP including both the technical processes and the behaviors necessary to optimize process execution
  • Develop and implement 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
  • Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses
  • Provides site and functions training, guidance and support as needed
  • Collaborate with other GPOs, PLs and SMEs to define best practices and drive optimal execution of process across BMS and external partners
  • Ensure compliance with regulatory requirements relating to investigation, company policies and procedures
  • Ensure process alignment with evolving regulations
  • Lead across the matrix or manage high-priority, cross-functional teams
  • Maintains global expertise through ongoing training and participation in industry forums
  • Manage departmental operational expenses in alignment with allocated budget.
  • Manage alignment and allocation of resources to ensure adequate and timely regulatory and compliance support
  • Develop and utilize metrics and KPIs and CPO operating mechanisms to identify and assure programs' success and continuously improve
  • Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other GPOs and PLs
  • Provide leadership to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, metrics and training material changes; and use of appropriate change management and communication principles
  • Provide oversight to ensure continuity of process and support systems through major initiatives (e.g. integration, divestiture, or reorganization); serve/lead program teams or sub-teams, manage interim state of operations, ensure establishment of defined future state of processes, as applicable
  • Maintain awareness of Culture of Excellence across BMS and adherence to BMS core behaviors
  • Support development, approval, and execution for improvement projects, changes, validations and process risk evaluations.
  • Provide leadership and support for systems project teams and committees to ensure that all system issues and opportunities are accommodated in a timely, effective, and Right First Time manner
  • Required Travel 10 to 15 % for select process owner roles to ensure processes are globally designed and deployed in an effective and inclusive manner where extensive iterative process design development, training and sustaining of processes are required


Education:
  • Minimum of a Bachelor degreein a Natural Science, Pharmacy, or other Healthcare-related field
  • Master's Degree and/or PMP certification with 10 plus years experience in pharmaceutical industry in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferred
  • A minimum of 10 years of experience in quality operations
  • A minimum of 12-15 years of experience in pharmaceutical industry
  • Thorough understanding of company policies and regulatory requirements, and provide subject matter expertise in their relation to the management and documentation of product quality and serious breach investigations
  • Familiar with electronic quality system tools
  • Strong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality
  • Understanding of clinical development
  • Mastery of relevant Quality compliance processes and regulations, e.g. Good Manufacturing Practices (GMP)
  • A minimum of 5-7 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experience
  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes

Skills/Competencies:
  • Demonstrated influential leadership expertise and experience with senior level interactions and influence with GxP functional areas and Global Quality
  • Demonstrated Enterprise mindset to be able to think and act across functions and divisions
  • Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
  • Demonstrated people management experience
  • Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
  • Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities
  • Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines
  • Demonstrated change agility in anticipating and leading others through change and ambiguity
  • Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance


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 the resources to pursue their goals, both at work and in their personal lives.