Global Process Lead, Safety Risk Management Plan
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Global Process Lead, Safety Risk Management Plan
The Global Process Lead (GPL), Safety Risk Management Plan within Global Risk Management, Worldwide Patient Safety reports into the Global Process Owner (GPO), Safety Risk Management Plan and is based in Summit NJ, Princeton NJ, or Uxbridge UK.
The purpose of the Global Process Lead (GPL) role is to ensure consistent global leadership for the Safety Risk Management Plan (RMP) process in the BMS Quality Management System (QMS) framework. The GPL is accountable to drive Safety RMP process optimization and improvement, to ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the GxP QMS document hierarchy. The GPL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens and ensure that process interdependencies are accounted for and communicated. In addition, the GPL will collaborate with stakeholders to establish, track, and trend process metrics to achieve Quality Outcomes that ultimately drives continuous improvement for the Safety RMP process. Continuous collaboration and leadership with the Safety RMP Community of Practice (COP), Quality Councils, Local Process Owners (LPO), GPL/Global Process Owner (GPO) GxP network, and relevant Subject Matter Experts (SME) are expected.
The GPL reports into the Safety RMP GPO who is accountable to provide high-level oversight, set strategy for the process and ultimate decision making in optimizing and the ongoing sustainability of the process. The GPO will serve as executive oversight and primary decision-maker including, where applicable, budgetary decisions for assigned processes. The GPO will provide oversight to the GPL including working with the GPL to resolve escalated issues, endorse and monitor metrics to achieve Quality Outcomes, and support the Safety RMP COP and Quality Council activities.
- In close collaboration with the GPO, serves as the process lead for Safety RMP in the BMS QMS framework ensuring it remains in a state of control and is both effective and efficient with consideration given to oversight of global, local, and cross-functional aspects of process implementation.
- Serve as key point of contact for Safety RMP process alongside the GPO, and represent the Safety RMP process as required including on key BMS QMS initiatives and integration activities.
- Support the process architecture of the integrated GxP QMS, and lead activities designed to monitor and improve the process within the QMS framework.
- Work effectively across the organization by engaging with the broader GxP GPL/GPO network and local site or function process owners in designing and deploying QMS process improvements.
- Identify and track progress against key milestones (such as for continuous improvement initiatives) partnering with applicable business, quality and other enabling functions and any external providers to ensure overall success.
- Actively engage with leadership on key QMS initiatives (such as process optimization, process integration), and lead activities to ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion.
- Collaborate with cross-functional teams and navigate through ambiguity towards clear and actionable decisions for QMS and Safety RMP related topics.
- Participate/lead regulatory surveillance and benchmarking initiatives with peers to stay abreast of changes in regulations that affect impacted processes and to identify new ways of working and evolving technologies in this space.
- Define and lead the development of metrics and collaborate with stakeholders on standard queries and reports with system functionality to deliver metrics for review.
- Provide leadership for Safety RMP COP and Quality Council activities, including actively participating and collaborating to support the operation of these forums.
Develop, Deploy, and Maintain Assigned Processes:
- Maintain Safety RMP processes, procedures, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards, and BMS’ QMS principles of integrated, patient centric, and risk-based decision-making.
- Support deployment of global process by close cooperation with relevant functions and site/country leads.
- Provide training, support, and coaching as required and lead on outreach opportunities such as hosting Safety RMP Open Hours.
- Define and lead the Safety RMP COP, including roles, operating mechanisms, communication strategies, and levels of training and access.
- Liaise with BMS Quality Leadership Team and other functional leaders to identify and empower COP members.
- Provide leadership, coaching, and training for Safety RMP COP including both the technical processes and the behaviors necessary to optimize process execution.
- Define process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both process quality and process effectiveness aspects.
- Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors, supporting document requests, writing/reviewing responses, and supporting CAPA as required.
- Collaborate with stakeholders to drive optimal execution of Safety RMP process across BMS and external partners where appropriate.
- Support or manage related high-priority, cross-functional events.
- Maintains global expertise through ongoing training and participation in industry forums.
Continuous Process Improvement:
- Provide and communicate data and conclusions to GPO and GRM&IPS leadership as appropriate.
- Utilize metrics and CoP/Quality Council operating mechanisms to identify and prioritize process improvements. Provide strategic recommendations for QMS data-driven process improvements.
- Drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with the GPO/GPL network.
- 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 and support the Culture of Excellence for Quality across BMS.
IT System Support (where applicable):
- 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 and effective manner.
Department oversight and other tasks:
- Maintain knowledge of current RM regulations and future legislative/regulatory initiatives.
- Direct, hire, manage, develop, and mentor staff.
- Support the implementation of HR processes, workforce plans and succession plans.
- Provide scheduled and ad-hoc reports to the leadership team as required.
- Other responsibilities as assigned.
- Advanced scientific degree preferred.
- More than 10 years of relevant pharmaceutical industry experience (e.g., Pharmacovigilance, Risk Management, Quality).
- Significant understanding of Quality Management Systems.
- Significant understanding of RM regulations and implementation practices.
- Demonstrated leadership for cross-functional and multidisciplinary teams.
- Experience with internal audits and Health Authority inspections.
- Exemplary leadership skills with proven ability to foster partnerships across companies and organizational boundaries.
- Creative thinker, exceptional listening, and analytical skills, along with excellent written, verbal, and interpersonal communication skills.
- Strong strategic orientation with ability to translate into priorities and plans.
- Strong project management experience with proven track-record of managing cross-functional projects and ability to manage multiple, simultaneous projects.
- Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
- Demonstrated Enterprise mindset able to think and act across functions and divisions.
- Demonstrated people management experience.
- 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.
- Advanced user of Microsoft Office tools.
- Occasional travel required.
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.
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.
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