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.

Principle Objective of Position

This position is responsible for supporting the end user community for Celdox eventual BMS’s electronic document management System for all document types and workflows. This includes determination of how systems changes/improvements impact end user experience, issue tracking/escalation/troubleshooting and identifying/sharing of best practices to improve user experience and system adoption.

Major Duties and Responsibilities

Support the end user community of Celdox and BMS’s electronic document management system for all document types and workflows.

SME on Electronic document management system (EDMS) configuration, design and function.

Reviews System release updates, new functionality and system improvements to determine impact to end users and take appropriate action to prepare users for changes including leading the updating of training materials and procedures

Responsible for identifying negative trends and take appropriate action to resolve issues including escalation, troubleshooting and prioritization

Responsible for the maintenance of policies, SOPs, work instructions, tools, templates and training modules for EDMS tool.

Collects and shares best practices through direct communications and communities of practice

Demonstrated skills in designing and implementing quality electronic documentation systems and practices.

Lead or participate as part of cross-functional teams as subject matter expert for electronic documentation systems;

Collect system health metrics to identify trends and take appropriate action

Act as subject matter expert and business expert for workflows and system design

Responsible for communication of system status/changes to business users

Partners with IT to support user access and account provisioning

Provide crossfunctional support to other Quality Management systems

Required Knowledge/Skills/Qualifications

Education:

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).

Experience/Knowledge:

Knowledge of health authority regulations and practical experience applying regulations in Good Documentation Practices

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

Must have strong SDLC (software development life cycle) understanding and ability to execute applicable requirements (e.g. UAT script creation)Proactively engages and supports end users and encourages user adoption.

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)

OPEX/Lean Six Sigma experience preferred

Experience with Veeva Quality Vault a plus

Skills/Competencies:

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com