Senior Manager, QA - Validation

Company: GSK
Location: Cambridge
Posted on: January 21, 2023

Job Description:

Site Name: Cambridge Binney Street
Posted Date: Jan 11 2023

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

We're looking for an exceptional Senior Manager, QAV, to join the Quality Assurance team. With excellent technical, operations, communication, and quality assurance skills, you'll be given the opportunity to work directly with Manufacturing, Facilities, Engineering, Validation and QC staff to review and approve validation related documents.

Key Responsibilities

• Provide quality and compliance oversight for Commissioning, Qualification, Validation of Facilities, Utilities, Systems and Equipment.
• Review and approve project plans, SIA's, URS's, DQ's, RA's, Validation protocols, Summary reports, SOPs, Specifications, and other applicable validation documentation.
• Work with a cross-functional team on validation related Deviations, CAPAs, and Change Controls.
• Support technical and quality investigations.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Collaborates with functional departments to resolve issues.
• Demonstrate understanding and knowledge of Equipment Qualification, Utilities Monitoring and Qualification, SIP/CIP Validation, Lab Instrumentation Qualification, CSV.
• Additional duties and responsibilities as required.
  Why you? Basic Qualifications:
  • 5+ years of industry experience in QA or Validation for a biopharma company.
  • Proficiency with MS Office- Word formatting. Excel for analysis and graphing.
  • Excellent written and oral presentation skills.
  • Creative thinking, multi-tasking and ability to work in a matrix environment.
    Preferred Qualifications:
    • A Bachelor's degree (or higher) in Chemistry, Biology, Engineering, or related field.
      Why GSK?
      
      We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
      
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      GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
      
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Keywords: GSK, Cambridge , Senior Manager, QA - Validation, Executive , Cambridge, Massachusetts