Adzuna logo

Director, R&D Quality Process Lead - ICSR Management

Location: Hillingdon
Company: Bristol-Myers Squibb
Apply for this job
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 (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
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, e.g. 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 (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
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
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: R1529211-en-us-2
Updated: 2021-03-07 01:58:52.604 UTC
Location: Hillingdon,United Kingdom
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.
Apply for this job


The number of jobs in each salary range for all:

Similar jobs

Quality Manager
JOBSWORTH £53,318 P.A.
London, SE11
Quality Director
JOBSWORTH £53,340 P.A.
Air Products
Hersham, England, KT12
Training and Quality Lead
From £30,000 to £35,000 per annum
Unicorn Recruitment Limited
Director, R&D Quality Process Lead - Management
JOBSWORTH £65,954 P.A.
Bristol Myers Squibb
Hillingdon, UB10
Process Quality Lead - London
JOBSWORTH £31,841 P.A.
Quality Manager