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Quality Systems Senior Manager

Company: Adecco Group
Location: New Brunswick
Posted on: February 22, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.--In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Manage People

  • Provide regular feedback and coaching to reports
  • Develop direct reports through coaching, mentoring, training and providing them with development opportunities
  • Build a team culture committed to high performance
  • Build effective working relationships both internally within EXM and within BMS Process Ownership
    • The Quality Systems Senior Manager will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing.
    • The Quality Systems Senior Manager will also be accountable for overseeing the work of Process Owners within their teams.
      • Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicable
      • Display technical knowledge of the process and understand risks/weaknesses in the system
      • Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/ directives where applicable.
      • Responsible for ensuring the elements of the process are current and reflect current practices
      • Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
      • Regularly review the process (trends metrics, trends observations, RFT, Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
      • Own relevant process issues - speak to trends/issues/exceptions at ExM Tier 3 Quality Councils
      • Own Health Authority commitments related to the process
      • Act as the subject matter expert in audits / inspections
      • Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance Processes include Deviation Investigations, CAPA, complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management. --Operations Support
        • The Quality Systems Senior Manager will be responsible for ensuring appropriate support is provided by Quality Services regional teams to ExM Operations from a Quality Systems and Training perspective on a day-to-day basis. Evaluate metrics collection and processing, including:
          • Capture and report on Quality data and metrics for management review and other organizational forums.
          • Utilize data analysis or software skills to build on existing tools to improve the quality system processes.
          • Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyse data and information. Other Ad hoc duties will be required which will include but not be limited to the following:
            • Author, review and approve QMS documents
            • Process QMS documents in the electronic document management system
            • Oversee Permanent Inspection Readiness activities
            • Escalate risks for inclusion in the Quality Risk Register for ExM
            • Responsible for the Document Management and Record Management systems
            • Responsible for the ExM Training Program
            • Oversee the system for maintenance of ExM GxP Authorizations
            • Act as facilitator and reviewer of Quality System Framework updates
            • Act as ExM Quality Services representative on ExM and Global Quality projects
            • Oversee the scheduling, execution, reporting, follow up and tracking of self-inspections audits.
            • Responsible for the preparation of Quality Council meetings
            • Review regulatory inspection observations from other BMS sites for site compliance.
            • Identify and implement continuous improvement opportunities for Quality Services owned processes
            • Act as qualified trainer for Quality Services owned processes. There will be 10% travel associated with this role. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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 with the resources to pursue their goals, both at work and in their personal lives.

Keywords: Adecco Group, New Brunswick , Quality Systems Senior Manager, Executive , New Brunswick, New Jersey

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