Global Process Lead: Audits and Inspections

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: May 16, 2022

Job Description:

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.Overall responsibilities In close collaboration with the Global Process Owner, serve as the process lead for the Audits and Inspections processes ensuring they remain in a state of control and are both effective and efficient Supporting the Audits and Inspections process architectures of the integrated Quality Management System (QMS), lead process workstreams designed to monitor and improve the process(es) within the integrated GxP QMS framework Work effectively across the matrix by engaging with the broader process owner network and local site or function process owners in designing and deploying QMS process improvements for Audits and Inspections. Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project success Actively engage with leadership from business case development through Audits and Inspections program delivery, broker the delivery of these critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion Navigate cross-functional team through ambiguity towards clear and actionable decisions Participate/lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect Audits and Inspections and other impacted processes and also to identify new ways of working and evolving technologies in this space Define and lead the development of metrics through standard queries and reports with system functionalityDevelop, Deploy, and Maintain Assigned Processes Maintain Audits and Inspections global processes, procedures, 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 Support deployment of these global process by close cooperation with relevant functions and site/country leads Provide training, support, and coaching as required Define Community of Practices (COPs), including roles, operating mechanisms, communication strategies, and levels of training and access Liaise with Quality Leadership Team and other functional leaders to identify and empower COP members Provide leadership, coaching, and training for applicable COPs including both the technical processes and the behaviors necessary to optimize Audits and Inspections process execution 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 Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses Collaborate with other GPLs and SMEs to drive optimal execution of process across BMS and external partners Support or manage high-priority, cross-functional events Maintains global expertise through ongoing training and participation in industry forumsContinuous Process Improvement Utilize metrics and COP operating mechanisms to identify and prioritize Audits and Inspections and other Quality process improvements Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other GPLs Lead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles 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 initiatives across BMS (e.g. Inspection Excellence) Required Travel up to 25% for select global process lead 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.IT System Support Support development, approval, and execution of business case approval for improvement projects Serve on systems project teams and committees to ensure that all system issues and opportunities are accommodated in a timely, effective, and Right First Time mannerEducation: Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field (Advanced Degree preferred).Experience/Knowledge: A minimum of 10 years of experience in Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e., research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) Knowledgeable of GxP regulations and expectations for core health agencies; thorough understanding of regulatory requirements in relation to Audit and Inspections Familiar with electronic quality system tools Strong program and project management experience with proven track-record of managing cross-functional programs and ability to manage multiple, simultaneous projects Familiarity with developing and executing organizational change, including change management strategy and planning Ability to set priorities and deliver results without constant feedback/input from manager Ability to identify, manage, and/or escalate issues and risks to timelines Ability to influence, initiate, and manage changeSkills: Demonstrated influential leadership expertise and experience with senior level interactions 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 Ability to communicate with presence and influence in both formal and informal settings, preparing and presenting persuasive written and verbal materials with employees and management at all levels 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 Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting prioritiesAround 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.Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.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. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit careers.bms..... click apply for full job details

Keywords: Bristol Myers Squibb, New Brunswick , Global Process Lead: Audits and Inspections, Other , New Brunswick, New Jersey