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NONovartis Pharmaceutical Manufacturing GmbH

R&D Quality Lead(m/w/x)

Schaftenau
from 78,383.9 / year
Full-timeOn-siteExperienced
Apply now

Oversight of R&D quality assurance and compliance for health authority regulations. GxP and cGMP experience required. Support for applicants with disabilities.

Requirements

  • Audit & Inspection Management
  • Quality Management Systems
  • Quality Assurance
  • GxP Experience
  • Good Manufacturing Practices (cGMP)
  • People Management
  • Quality Compliance
  • Drug Development
  • Research
  • Technological Expertise
  • Complaints Management
  • Good Laboratory Practice (GLP) Analytics
  • Incident Management
  • Deviation Management
  • Patient Safety
  • Pharmacovigilance
  • English proficiency

Tasks

  • Provide quality assurance and compliance oversight
  • Drive quality management systems and initiatives
  • Ensure compliance with health authority regulations
  • Role model good quality behaviors
  • Promote a culture of quality
  • Develop and support quality plan initiatives
  • Provide QA expertise and guidance
  • Implement quality risk-based and GxP processes
  • Lead and manage a QA organization
  • Collaborate with business partners and quality groups
  • Translate QA strategy into operational activities
  • Support risk-based process implementation
  • Address and sustain quality and compliance gaps
  • Implement strategic process improvements
  • Review procedural updates and training
  • Conduct effectiveness checks
  • Monitor Quality Plan implementation
  • Support inspection readiness activities
  • Participate in regulatory inspections
  • Manage inspection preparation and follow-up
  • Oversee external service providers and IT systems
  • Facilitate and follow up on audits and inspections
  • Develop and implement corrective and preventive measures
  • Escalate deviations and incidents timely
  • Conduct robust investigations and root cause analysis
  • Implement corrective actions
  • Contribute to lessons learned
  • Report technical complaints and adverse events within 24 hours
  • Distribute marketing samples where applicable

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • English – Native

Benefits

Other Benefits

  • Adjustments for applicants with disabilities
  • Involvement of local disability representative (BVP)

Diverse Work

  • Advice on suitable positions

Mentorship & Coaching

  • Guidance at all stages of the application process
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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