Hybrid Senior Manager, RCI & CAPA

Posted 2 months ago

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About the role

  • Lead CAPA and root cause investigations in a global biopharma company. Collaborate with various stakeholders to improve issue management and ensure compliance.

Responsibilities

  • Lead end-to-end root cause investigations for cross-functional and high-risk issues, using structured methods to reach evidence-based conclusions
  • Coach and support colleagues on investigation tools, risk assessment and SMART CAPA design
  • Oversees the CAPA closure and effectiveness implementation
  • Partner with process owners and stakeholders to simplify workflows, reduce recurrence and improve issue management practices
  • Facilitate the management review and oversight by proactively monitoring signals and business performance
  • Assess Issues for criticality and Serious Breaches

Requirements

  • Degree in a life science, engineering, quality, or related field, or equivalent experience
  • Significant experience in issue investigation, CAPA management, quality or risk roles within pharmaceutical, vaccines, or life sciences settings
  • Demonstrated experience leading root cause analyses and implementing CAPAs in a regulated environment
  • Strong knowledge of quality management systems and applicable regulatory expectations
  • Proven ability to influence across a matrix organisation and lead cross-functional teams

Benefits

  • competitive salary
  • annual bonus based on company performance
  • healthcare and wellbeing programmes
  • pension plan membership
  • shares and savings programme
  • private healthcare
  • additional paid days off
  • life insurance
  • private pension plan
  • fully paid parental leave & care of family member leave

Job title

Senior Manager, RCI & CAPA

Job type

Experience level

Senior

Salary

PLN 293,250 - PLN 488,750 per year

Degree requirement

Bachelor's Degree

Location requirements

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