Director amp Global Process Owner Business Continuity Planning

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.

Principle Objective of Position

The purpose of this role is to provide strategic and tactical direction and oversight to ensure consistent global leadership for the Business Continuity Planning process defined as part of the Quality Management System Architecture. The BCP Global Process Owner (GPO) will provide decisions required and oversight to Process Leads (PL), who is accountable to drive initial process optimization and improvement following standard methodology to align with the GxP document hierarchy and responsible to sustain and drive continuous improvement post-implementation including the development of process metrics to achieve quality outcomes . The GPO will work closely with GxP QRM function, build networks across GPS, R&D & IT Business areas and will local site BCP owners, also driving Community of Practice forums with other PLs, Local Process Owner (LPO), and Subject Matter Experts (SME).

The 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.

Major Duties and Responsibilities


Own the Business Continuity Planning (BCP) process from a GxP perspective, and work closely with the GxP QRM function to utilize best practices including principles, tools and processes across GxP landscape.
Build networks across the GPS, R&D and IT business areas and with local site BCP owners to ensure an integrated approach across the GxP regulated area.
Serve as the the liaison between the Global Quality Unit and the BCP teams during a crisis management situation
Own inspection readiness relative to crisis management
Support GPS, R&D, and IT Business Units, together with Site BCP owners, with test exercises to check and improve BCP and crisis management processes; improvements should be made to global GxP BCP processes as applicable
Define the process for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
Ensure all relevant Quality / Fusion Level 2 Processes include BCP (e.g., CSV, Vendor Management, Global Deviations, Facility Restart, HA Communications)
Define which Global Quality Events are escalated to the BCP process
Continually improve BMS response to GxP BCP after undergoing a crisis management situation
Accountable for the effective and efficient execution of the BCP 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
Ensure role definition and clarity on key accountabilities for process steps through an enterprise lens
Lead and assure alignment of GxP BCP 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 GxP BCP QMS
Provide strategic leadership for establishing and maintaining a robust compliant investigation program across the end-to-end product lifecycle (GPS and R&D), supporting IT Systems, and across all BMS sites 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, R&D/GPS/IT 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
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 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
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 25 to 50% 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


Required Knowledge/Skills/Qualifications

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


Experience/Knowledge:


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 Business Continuity and Crisis Management
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 and product quality
Mastery of relevant Quality compliance processes and regulations, e.g. Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Pharmacovigilance Practice (GVP)
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


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: R1527010_EN

Updated: 2020-06-30 00:00:00.000 UTC

Location: New Brunswick,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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