iSixSigma

Global Process Lead, QMS Procedural Documents and Governance Controls (Associate Director)

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Bristol-Myers Squibb
Published
March 9, 2021
Location
New Brunswick, NJ
Job Type

Description

The purpose of this role is to ensure successful implementation and operational execution of the QMS Document Management process specific to procedural documents (policies, global SOPs, global work instructions, and related documents) across the GxP Quality Management System Framework processes to ensure compliance with the QMS Operating Model and QMS hierarchy. This role will support the Global Process Owner (GPO) and Global Process Lead (GPL) of QMS Document & Record Management to drive integration activities across heritage organizations responsible for GxP related activities.

The position reports into the Director, GPO of QMS Document & Record Management under QMS Governance Controls.

Major Duties and Responsibilities

  • In close collaboration with the GPO and GPL for QMS Document and Record Management, serve as the Lead to drive implementation activities for the integrated and optimized QMS Document Management process across GxP sites and functions inclusive of GLP, GCP, GVP, clinical and commercial GMP, and GDP
  • Lead the design and deployment of the global translation process and global QMS glossary
  • Manage revision of the BMS Quality Manual, Master QMS Framework, and associated documents and activities
  • Create necessary work instructions and job aids to supplement the QMS Document Management process during implementation, hypercare and sustainability phases of integration
  • Assess operating mechanisms and communication strategies to ensure active engagement of members of the QMS Document Community of Practice
  • Improve and maintain the QMS Document Management sharepoint site in collaboration with the QMS Operational Controls and Lifecycle Management Document Teams
  • Support integration and optimization of Governance Controls processes as Document Manager following standard methodology to ensure compliance with QMS operating principles
  • Support the design, implementation and deployment of the single integrated electronic document management system for BMS
  • Identify and track progress against key project milestones partnering with applicable business, quality, and other enabling functions and any external providers to ensure overall project success
  • Identify and drive continuous process improvement initiatives
  • Support change control, impact assessment, PQ testing, document updates and training for electronic document management system updates and releases

Education

  • Minimum of a Bachelor’s degree required in relevant field

Experience/Knowledge

  • 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)
  • Knowledgeable of GxP regulations and expectations for core health agencies; expert knowledge specific areas related to this role
  • Familiarity with developing and executing organizational change, including change management strategy and planning
  • Project management experience with proven track-record of managing programs and ability to manage multiple, simultaneous projects
  • Ability to set priorities and deliver results without constant feedback/input from manager
  • 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
  • OPEX/Lean Six Sigma experience a plus

Skills/Competencies

  • Change agility and leadership in anticipating and leading others through ambiguity by continuously creating context and engaging individuals in what it means for them
  • Ability to communicate with presence and influence in both formal and informal settings, preparing and presenting persuasive written and verbal materials to executive-level leadership and/or large audiences
  • Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
  • Strong technical writing skill
  • High degree of competency in MS Office Suite, including Visio, PowerPoint, Excel, & Word

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