Associate Director, Quality and Risk Management, Clinical Unit Cambridge

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom GlaxoSmithKline Full time

Site Name: UK - Cambridgeshire - Addenbrookes

As the Associate Director, Quality and Risk Management, at GSK, you'll collaborate with the research team at the Clinical Unit Cambridge (CUC) to ensure top-notch clinical care during clinical trials and experimental studies. Your role involves working closely with Principal Investigators, research physicians, nurses, technicians, and managers.

Joining the Clinical Quality Assurance team, you'll engage with colleagues in Global Quality and Risk Management to drive quality activities for Human Subject Research. This includes QA audits, Issues Management, and Regulatory Inspection Management. The role also entails supporting the Global Process governance framework.

This on-site role provides a space for growth, safety, and a sense of belonging. GSK offers a competitive salary, annual bonus, healthcare programs, pension plan, and more.

Key Responsibilities:

  • Regulatory Compliance and Quality Oversight: Ensure compliance with Regulations and Guidelines, overseeing staff at the CUC site.
  • Regulatory Agency Inspections: Coordinate inspections and lead the inspection team.
  • Internal Audits: Coordinate internal audits and manage significant deviations.
  • Issue Management: Lead investigations and root cause analysis of deviations.
  • Risk Management: Partner with risk management stakeholders to address significant risks.
  • Written Standards and Controls: Support SOP implementation and deviations management.
  • Management Monitoring: Identify controls for business activities and track performance.
  • Training: Identify training needs for quality and compliance.

Why you?

Basic Qualifications & Skills:

  • Bachelor of Science or equivalent in a life science field.
  • Knowledge of Regulations, legislation, and experience in a quality role.
  • Experience in phase 1 clinical trials, leadership skills, and teamwork.

Preferred Qualifications & Skills:

  • Advanced degree or equivalent experience, management of Quality Systems.
  • Experience in a phase I Quality organization.

Closing Date for Applications - 17 June 2024 (COB)

Interested individuals must describe how they meet the competencies for the role in their application. GSK's mission is to positively impact the health of billions of people by delivering transformative vaccines and medicines and uniting science and technology.

Why GSK?

GSK focuses on uniting science, technology, and talent to combat diseases and improve the health of billions worldwide. Their core therapeutic areas include infectious diseases, HIV, respiratory/immunology, and oncology.

At GSK, you're encouraged to thrive, grow, and contribute to meaningful work. An agile working culture ensures flexibility and diverse talent is welcomed. GSK values inclusion and diversity in its workforce.

Important notice to Employment businesses/Agencies

GSK does not accept referrals from employment agencies without authorization. For US Licensed Healthcare Professionals, GSK may report expenses for interviews to comply with transparency requirements.

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