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Senior Specialist, Quality Systems

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: June 10, 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.

Description:

  • The Quality System Senior Specialist will carry out duties relevant to Quality Systems processes within Global External Manufacturing.
  • Carry out Quality Systems duties relevant to 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
  • Support subject matter expert for review of regulatory or directive changes.
  • 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
  • Carry out activities to implement Health Authority commitments related to the process
  • Support the subject matter expert in audits / inspections
  • Participate in pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance

Quality Systems include Product Quality Complaints, Deviation Investigations, CAPA, complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management.

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
  • 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 Authorizations
  • Act as facilitator and reviewer of Quality System Framework updates
  • Act as ExM Quality System 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 System owned processes
  • Act as qualified trainer for Quality Systems owned processes.

Required Qualifications:

  • A science related degree in Chemistry, Engineering or Biotechnology
  • A minimum of three (3) 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

Desired Qualifications:

  • Experience in a GxP Manufacturing site
  • Technical writing training / qualification
  • Lead investigator training
  • Qualified auditor
  • Lean Six Sigma qualification
  • Project Management qualification
  • Supervision of work of direct or indirect reports

There will be 5% 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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Keywords: Bristol Myers Squibb, New Brunswick , Senior Specialist, Quality Systems, Other , New Brunswick, New Jersey

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