Novartis

Clinical Quality Assurance Program Lead – Associate Director

Novartis

full-time

Posted on:

Location Type: Hybrid

Location: London • United Kingdom

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities)
  • Drive implementation of quality strategy within Global Clinical Team (GCT)/ Clinical Trial Team (CTT) under responsibility
  • Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies
  • Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities and ensure that Clinical Trial Process (CTP) are in control
  • Provide robust and clear quality oversight in the following areas of clinical development
  • Support/collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and/or CTT members) to ensure that risks are detected and remediated
  • Support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required
  • Provide Good Clinical Practice (GCP) guidance to day-to-day questions arising from Clinical trials deliverables
  • Collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities Quality oversight
  • Lead inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ)
  • Support audits and inspections follow-up activities including Corrective & preventative Actions (CAPA) preparation
  • Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct
  • Active participation in continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability
  • Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes

Requirements

  • Bachelor’s degree in life science or healthcare field required
  • Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/ PharmD/ Masters)
  • 7 years of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development
  • Ability to work independently and in a global/matrix environment
  • 3 or more years’ experience in managing projects
  • Strong skills in GCP, quality and/or clinical development
Benefits
  • 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Good Clinical Practice (GCP)quality risk managementclinical developmentPharmacovigilance (PV)quality oversightCorrective & Preventative Actions (CAPA)audit preparationinspection readinessproject managementquality strategy implementation
Soft Skills
leadershipcollaborationcommunicationindependenceorganizational skillsproblem-solvingstakeholder engagementcontinuous improvementrisk managementdecision making
Certifications
Bachelor’s degree in life science or healthcarePhDMDPharmDMasters