Associate Director Product Quality Support Surveillance

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Bristol Myers Squibb
Associate Director, Product Quality Support Surveillance
in
New Brunswick
New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Summary:
Develop and assure outstanding execution of product quality support metrics collection, reporting and messaging with focus on product complaints, product surety and serialization. Responsible for the collection, reporting, and continuous improvement of compliance-focused metrics within GPS including, but not limited to Global Metrics/Scorecards, Global Quality Council Metrics and Health Authority requests. Analyze metrics and develop key messaging for review and approval by relevant subject matter experts.
Responsibilities:
Report on monthly and YTD metrics on key Quality compliance indicators.
Review signals and trends that may present a risk to the organization, and prepare summary of potential CAPAs.
Provide recommendations and communications based on output from analytical tools and visualizations.
Provide risk assessment support for quality activities
Continuously improve process for assessment and reporting data to drive consistency and understanding of Quality compliance-focused metrics.
Use Operational Excellence and similar approaches to support the design of metric tools that facilitate proactive discussion and provide visibility/transparency to drive continuous improvement, prioritization and product quality related decisions.
Lead teams in the development of tools and reports to standardize metrics.
Coordinate collection and review of data in response to health authority requests.
Lead metrics initiatives related to product quality complaint programs and processes.
Facilitate and drive standards for communication, management and visibility of product quality support metrics.
Implementation and timely update of information to ensure content is current and accurate.
Establish appropriate procedural documents for product quality support metrics
Cross train in other areas of the Global Quality organization to assist the business in developing its employees.
Perform other duties as assigned.
Required Knowledge/Skills/Qualifications
Education:
Bachelor of Science degree in statistics/biostatistics, engineering, chemistry, biology, or other quantitative field. Advanced degree preferred. ​
Experience/Knowledge:
A minimum of 8-10 years of experience in pharmaceutical industry
Experience in pharma or biotech industry with demonstrated successful performance in Product Quality Complaint Management and communications, Quality Engineering and/or comparable functional areas is required.
Strong working knowledge/experience with systems such as QMS, SAP/ERP, Veeva etc.
Experience with understanding how to respond to trend signals within the context of quality surveillance
Strong problem solving skills are required
Strong program and project management
Ability to manage multiple, simultaneous projects
Thorough understanding of Quality Risk Management
Mastery of relevant Quality compliance processes and regulations
Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological
Skills/Competencies:
Excellent communication with management, peers, and other functional areas
Ability to work well cross-functionally with R&D, Regulatory Affairs, Business Insights & Analytics (BIA), Technical Disciplines and all GxP functional areas
Proven ability to understand complex processes/problems and propose alternate solutions
Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders
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
Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats
Demonstrated strategic thinking capability and ability to balance conflicting priorities
Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance
Ability to clearly articulate analytical needs to functional partners such as BIA and IT
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 the resources to pursue their goals, both at work and in their personal lives.
Company:****
Req Number:
R1521609_EN
Updated:
2020-05-21 00:00:00.000 UTC
Location:
New Brunswick,New Jersey
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.

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