Associate Director EDMS

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

The core responsibility of this position is overall business system ownership of BMS’s electronic EDMS (Electronic Document Management System) and will support the implementation of the to be EDMS system. This will include the identification, prioritize and manage the execution (inclusive of data migrations) for the new process and workflows, ongoing system management of the Document Management System across all Gxps. Additionally, prior to EDMS implementation, this position will be the system owner for Celdox (Veeva Doc management platform).

Major Duties and Responsibilities

Acts as business owner of BMS’s EDMS

Subject matter expert and business expert for workflows and system design

Define and maintain system health metrics to identify trends and take appropriate action

Responsible for communication of system changes to business users

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

Responsible for business continuity documentation and processes to avoid supply dispruptions

Owns policies, SOPs, work instructions, tools, templates and training modules for EDMS.

Responsible for development of system for archival of electronic records;

Ensures the documentation system is scalable and flexible to support acquisitions, new product launches, product in-license operations and new market opportunities, and other initiatives;

Acts as Global Quality business lead for enhancements/improvements

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

Develops and maintain a continuous improvement plan

Partners with IT to exexute the strategy

Reviews and approves GxP impact assessments for new releases/improvements

Responsible for user requirements

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

Responsible for development and execution of User Acceptance Testing

Celdox System

Business Owner, Responsible and accountable for managing the global electronic and physical record GMP/GDP documentation system in compliance with regulatory requirements, company requirements and procedures;

Global Business Lead for enhancements/Improvements

SME for Integration

Required Knowledge/Skills/Qualifications

Education:

Minimum of a Bachelor’s degree

8 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:

Subject matter expertise in 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

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, Operations, 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