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Quality Systems Manager

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: September 21, 2022

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.

Process Ownership

  • The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
  • Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
  • Act as primary ExM representative at Global Community of Practice meetings
  • Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
  • Own all elements of the process including relevant procedures / forms, training materials, SharePoint 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 Bristol Myers Squibb (BMS) policies / global procedures 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 changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
  • Ensure appropriate Key Performance Indicators are in place to measure the effectiveness of the system within ExM
  • Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimisation) 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 External Manufacturing Tier 3A and 3B Quality Council.
  • 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, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections. Operations Support
    • The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
      • Processing of Customer Complaint records, including escalation of expedited complaints
      • Support the processing of deviation investigations, CAPAs and change controls
      • Perform initial impact assessment of Global change controls that may impact ExM Operations
      • Participate in Virtual Plant Team (VPT) meetings as appropriate
      • Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required
      • Facilitate tracking of CMO Health Authority inspection observations and CAPAs
      • Escalate any emerging trends / issues to the VPTs, as required.
      • Provide Quality input ad hoc queries relating to ExM Operations
        • Support 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:
              • Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location
              • Author, review and approve Quality Management System (QMS) documents
              • Process QMS documents in the electronic document management system
              • Participate in and support Permanent Inspection Readiness activities
              • Maintain the Quality Risk Register for ExM
              • Monitor the periodic review of Quality Systems documents
              • Maintain the system and process for record management
              • Maintain the system for update of ExM GxP (Good Practice) Authorizations
              • Act as facilitator and reviewer of global procedural updates through the GPO network
              • Act as ExM Quality Systems representative on ExM and Global Quality projects
              • Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits
              • Support preparation of and participate in Quality Council meetings
              • Perform self-inspection audits as part of the audit team
              • Review regulatory inspection observations from other BMS sites for site compliance
              • Identify and implement continuous improvement opportunities for Quality Systems owned processes
              • Act as qualified training for Quality Systems owned processes
              • There will be 5% travel associated with this role. Requirements:
                • A science related degree in Chemistry, Engineering or Biotechnology or equivalent
                • A minimum of seven (7) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
                • A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
                • Knowledge of OPEX tools
                • Experience in leading or participation in project teams
                • Works under minimum supervision and exhibits a positive work attitude and high productivity
                • Detail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skills
                • Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines
                • Excellent interpersonal skills
                • Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated
                • Strong presentation skills; confident public speaker
                • Ability to multi-task numerous projects
                • Ability to achieve targets and milestones
                • Can prioritize workload based on changing business needs
                • Ability to recognize topics / decisions requiring escalation
                • Ability to work with initiative and manage own workload
                • Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
                • Fluent English is required. For roles based in Switzerland, French is also desired.
                • Strong working knowledge of Microsoft OfficeDesirable:
                  • Experience in a GxP Manufacturing site
                  • Technical writing training / qualification
                  • Lead investigator training
                  • Qualified auditor
                  • Lean Six Sigma qualification
                  • Project Management qualification

                    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.

                    Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

                    To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

                    Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S..... click apply for full job details

Keywords: Bristol Myers Squibb, New Brunswick , Quality Systems Manager, Executive , New Brunswick, New Jersey

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