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You will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across research and development and related functions. You will work closely with quality, safety, clinical and regulatory to resolve complex issues and reduce future risk. We value clear thinkers who listen, influence with empathy, and drive practical, data-led solutions. This role offers visible impact, real career growth and the chance to shape processes that help us unite science, technology and talent to get ahead of disease together.
Job Responsibility:
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
Comfortable working in a hybrid model, with an expectation to be on-site regularly
Nice to have:
Advanced degree (MSc, PhD or equivalent) in a relevant discipline
Formal training or certification in root cause analysis, Six Sigma, Lean or similar methodologies
Experience supporting regulatory inspections or preparing for audits
Experience of assessing Issues for criticality and Serious Breaches
Track record of process improvement and measurable impact through CAPA effectiveness
Experience working with digital tools for quality management, analytics or workflow tracking
Familiarity with global regulatory frameworks and guidance relevant to clinical and quality activities
What we offer:
Competitive base salary
Annual bonus based on company performance
Flexible working options
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Pension plan membership
Shares and savings programme
Private healthcare (Poland)
Additional paid days off (Poland)
Life insurance (Poland)
Private pension plan (Poland)
Fully paid parental leave & care of family member leave (Poland)