Bristol Myers Squibb Company

Associate Director, Product Quality Support Surveillance

Location
New Brunswick, NJ, United States
Posted
Sep 03, 2020
Ref
R1521609
Required Education
Bachelors Degree
Position Type
Full time
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.

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


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.