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Director, R&D Quality Process Lead - Management

Posted on Apr 6, 2021 by Bristol-Myers Squibb

Princeton, NJ 08540
Research
Immediate Start
Annual Salary
Full-Time


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.


Principle Objective of Position


The purpose of this role is to ensure consistent global leadership for key R&D Quality processes within WWPS. This role focuses on all aspects of individual case safety reporting (ICSR) processes. The Process Lead (PL) is accountable to drive initial process optimization and improvement following standard methodology, ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the GVP document hierarchy. This will include serving as the key point of contact for assigned processes. The PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens. The PL will establish, track, and trend process metrics to achieve Quality Outcomes and will lead Community of Practice with Local Process Owner (LPO), other Process Leads (PL), and Subject Matter Experts (SME).


The PL role reports into the Global Process Owner (GPO) who is accountable to provide high-level oversight and decision making in optimizing and ongoing sustaining of the process. The GPO will serve as executive oversight and primary decision-maker for assigned processes. The GPO will provide decisions required and oversight to Process Leads (PL), endorse metrics to achieve Quality Outcomes, and support Community of Practice.


Major Duties and Responsibilities


Overall responsibilities


Lead a workstream for a large global GVP Quality Management Systems (QMS) Optimization project


Cultivate business relationships to provide program leadership in a highly matrixed environment


Actively engage with leadership from within WWPS and external organizations to ensure alignment on scope, schedule, quality, benefits and to implement and monitor appropriate controls to proactively deal with barriers to completion


Navigate cross-functional team through ambiguity towards a clear and actionable decision


Participate/lead benchmarking initiatives with peers externally to stay abreast of new ways of working and evolving technologies in this space


60%- Develop, Deploy, and Maintain Assigned Processes


Maintain global processes, procedures, and training materials in compliance with Global GCP and GVP requirements, BMS Global Quality Standards, and BMS' Quality Management System (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


Define Community of Practice (COP), 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 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 quality, compliance and process effectiveness aspects


Support the organization during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses


Collaborate with other PLs 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 forums


30%-Continuous Process Improvement


Utilize metrics and COP operating mechanisms to identify and prioritize 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 PL


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 (eg 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


10%-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 manner


Required Knowledge/Skills/Qualifications


Education


Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field, Master's Degree, PharmD or MD preferred. At least 5 years of Pharmacovigilance experience including GVP expertise


Experience/Knowledge


General


Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of quality issues, audit findings, clinical non-compliance, and serious breach investigations


Strong program and project management experience with experience managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality and Compliance


Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities


Experience with partner management


Specific to relevant GVP processes


Understanding of pharmacovigilance regulations and guidances, including interventional and noninterventional clinical trials and postmarketing requirements


Mastery of relevant Quality compliance processes and regulations, eg Good Clinical Practices (GVP)


A minimum of 5 years of pharmacovigilance or other relevant biopharmaceutical industry experience


Skills/Competencies


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 (eg 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


Developmental Value


Develop Enterprise mindset and ability to navigate cross-functionally


Develop subject matter expertise in various GCP process areas


Develop continuous improvement mindset


Develop leadership and communication capabilities


Gain responsibility for operational improvements


Gain exposure to executives across different functions




Reference: 1152691825

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