Manager Global QMS Programs

Profile

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.

This position has overall accountability for managing critical data elements within BMS’s electronic Quality Management System (QMS) called Infinity and will lead the development and management of QMS processes to ensure the system data is accurate and contemporaneous across the following workflows: Change Management, Investigations, Complaints, Audits, CAPAs, Stand Alone Actions and Notification-To-Management.

Responsibilities:


Act as the QMS Data Lead for BMS’s electronic QMS (Veeva Quality Vault branded as Infinity) across the following work flows: Change Management (Development & Commercial), Investigations, Action Management, Audits & Findings, Product Quality Complains and Notification-To-Management

Primary owner of system data and processes to ensure that data is kept current

Subject matter expert and business expert for workflows and system design

Define and maintain data quality metrics to identify trends and take appropriate action

Responsible for communication of system status/changes to business users

Provide support from business perspective on internal/external system audits and regulatory agency inspections

Owns policies, SOPs, work instructions, tools, templates and training modules for Infinity Data Quality processes

Provides input and strategic direction for all Infinity enhancements including data and configurations changes

Contributes to the development and maintenance of the continuous improvement plan for Infinity

Work with end users to determine system enhancements for data management

Ensures that current data integrity requirements are being maintained and satisifed

Partners with IT to exexute the strategy and build robust processes

Reviews and approves GxP impact assessments for new releases/improvements

Responsible for data quality and data integrity user requirements

Reviews SDLC documentation including user/functional requirements, validation plans and summary reports


Qualifications:


Minimum of a Bachelor’s degree

5 years' experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).

Knowledge of health authority regulations and practical experience applying regulations in change control, investigations, complaints and audits

Knowledge of compendia, cGxP requirements, FDA regulations and the ability to interpret and apply them

Proven ability to understand complex processes/problems and propose alternate solutions (required based on need to design and implement global business processes and policies, which requires critical thinking and analysis skills)

Ability to set priorities and deliver results without constant feedback/input from manager (required based on level of responsibility).

Ability to identify, manage, and/or escalate issues and risks to timelines

Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders (required to ensure completeness and robustness of processes and ensures effective adoption of processes)

Ability to influence, initiate, and manage change

Organization awareness and ability to work well cross-functionally with R&D, Regulatory Affairs, Global Engineering, etc. (required as these are key stakeholders and partners in the development and implementation of global processes and policies)

Experience with Veeva Quality Vault a plus

Strong verbal and written communication skills

Project management skills


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.

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, disability or protected veteran status.

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