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Procedural Document Manager

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: March 27, 2020

Job Description:

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. Develop and/or revise global procedural documents to support the business unit processes in the Quality Management System (QMS) process framework 'Operations Controls'. Procedural management activities include, but are not limited to, working with subject-matter experts to ensure accurate document content and compliance with health authority regulations and expectations. This position is responsible for facilitating global procedural documents within operational controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution.

  • Responsible for lifecycle management of procedural documents and supporting documents within the Operational Controls of QMS process framework.
  • This includes, but not limited, to document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
  • Responsible for compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
  • Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and management.
  • Support Global Product Development & Supply organization as the SME for BMS electronic document management system.
  • Support strategic initiatives and continuous improvement projects related to QMS
  • Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes
  • Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans
  • Effectively manage projects, escalate issues as necessary and identify/meet key milestones
  • Work with limited guidance to manage the development of global procedural documents and, seek input as needed
  • Team leadership skills that contribute to meeting team goals and resolving complex issues
  • Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies
  • Collects and shares best practices through direct communications and communities of practice
  • Collect metrics to identify trends and take appropriate action
  • Responsible for communication of procedural document status to businesses 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 with demonstrated leadership in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities' regulations Experience/Knowledge:
      • In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement.
      • Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
      • Strong negotiating and influencing skills in a matrixed organization.
      • Ability to drive consensus, performance and to lead strategically
      • High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas
      • Ability to build teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner
      • Demonstrated ability to work independently and mentor team members
      • Ability to identify, manage, and/or escalate issues and risks to timelines Skills/Competencies:
        • Excellent technical writing skills.
        • Proficient in MS Office and Collaboration applications.
        • Experience with electronic documentation management systems.
        • Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
        • Strong verbal and written communication skills
        • Project management concepts, strategies and skills
        • Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures requires critical thinking and analysis 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.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Procedural Document Manager, Executive , New Brunswick, New Jersey

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