R&d Quality Manager (medical Devices And/or Combination Products)

Sandoz

Gxp regulatory compliance expertise
Root cause analysis and capa management
Health authority inspection support
The role provides quality assurance expertise to ensure compliance with GxP regulations and Novartis procedures across development and research organizations

Job Summary

  • The role provides quality assurance expertise to ensure compliance with GxP regulations and Novartis procedures across development and research organizations.
  • Key responsibilities include managing health authority inspections, generating Quality Plans for clinical programs, and leading root cause investigations for quality issues.
  • The position requires a leader who can proactively identify risks, manage corrective actions, and foster a culture of continuous quality improvement within the Sandoz team.

Matching Summary

The role provides quality assurance expertise to ensure compliance with GxP regulations and Novartis procedures across development and research organizations.

Skills & Requirements

Must-have

  • GxP regulatory compliance expertise
  • Root cause analysis and CAPA management
  • Health authority inspection support
  • Quality Plan generation and review
  • Risk management in clinical programs

Nice-to-have

  • Six Sigma methodology knowledge
  • Strong influencing and negotiation skills
  • Cross-boundary collaboration abilities
  • Agility in changing environments
  • Self-awareness and leadership qualities

Key Requirements

  • Functional breadth in critical negotiations
  • Project management experience
  • Knowledge of CAPA and change control
  • Experience with audit management
  • Proficiency in Standard Operating Procedures

Work Rights

Not specified

Tailored Resume

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