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
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