Director QBP managing quality strategies and compliance in life sciences industry. Leading quality initiatives and fostering collaboration with assigned teams and third parties.
Responsibilities
Act as the trusted quality partner for assigned functions and third parties.
Provide practical, clear quality advice and help teams reduce risk while improving processes.
Shape quality strategies that enable reliable delivery, support quality investigations, and inspection readiness.
Educate assigned groups on Quality by Design, regulatory compliance, and risk mitigation.
Collaborate with internal teams on audits, inspections, risk assessments, and issue management.
Define and monitor quality strategies and metrics for stakeholders.
Ensure communication of quality issues and risks to appropriate leaders and colleagues.
Guide investigations of potential serious breaches and critical quality issues.
Requirements
Bachelor’s degree in life sciences, pharmacy, engineering, or related discipline, or equivalent experience.
Minimum 5 years’ experience in quality, compliance, or regulatory roles within the life sciences industry.
Experience in drug development, regulatory compliance or quality management.
Experience in matrix management and leadership to cross-functional teams.
Expert knowledge and experience of GCP, GLP, GVP and regulatory requirements.
Ability to lead investigations, perform root cause analysis and deliver effective CAPAs.
Stakeholder skills with experience influencing cross-functional teams and senior leaders.
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