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Director, R&D Quality Process Lead - Management

Posted on Apr 6, 2021 by Bristol-Myers Squibb

Princeton, NJ 08540
Immediate Start
Annual Salary

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


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



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


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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