Director Audit, Inspection

Your Role

The Director Audit, Inspection & Performance Optimisation is responsible for creating and maintaining CSLs strategic framework for the lifecycle management and oversight of pharmacovigilance audits, inspections, and related process performance improvements.

Reporting to the Head of International Pharmacovigilance, this position leads in formulating the strategy, related procedures, guidelines, best practices, and tools that support Safety Officers (SO) globally.

You will ensure Pharmacovigilance (PV) audit/inspection readiness and management methods are implemented by identifying and implementing process optimisation initiatives.

Your Responsibilities
- Coordinate the implementation of inspection and audit readiness activities within Regions/Affiliates
- Support all global Quality forums to communicate the health of the Regions PV sub-system (e.g., PVSQC and Commercial Quality Council)
- Work with Regions Representatives and SOs as applicable to manage out-of-compliance activities/metrics and support the implementation of process improvement initiatives
- Support the PV audit process for affiliates/vendors across the globe
- Review/provide input to the Annual Audit Plan in close collaboration with Regional Heads & Safety Officers
- Oversee audit preparation activities, front and back-room support during audits, provide guidance/advice for audit responses to ensure consistency and alignment with local and global requirements
- Ensure issues or non-compliances identified during audit/inspection readiness are managed and escalated in accordance with CSL deviation and issue escalation process
- Implement proactive PV change management activities for Regions and Affiliates to support audit/inspection readiness, ensuring Regions/Affiliate appropriate change planning
- Ensure Regions/Affiliate/vendor CAPA generated from audits and inspections are followed up and closed in a timely manner in close collaboration with auditee and auditor
- Drive the uptake of a Regions/Affiliate audit/Inspection ready mindset, mentoring and coaching personnel to implement audit/Inspection readiness activities
- Monitor industry trends, best practices, and experiences applicable to GCSP Regions and SOs, related to PV audits, inspections and process optimisation

Your Experience
- Degree (Bachelor/Masters/Diploma) in a Business related or scientific/medical/pharmaceutical discipline
- 10+ years' experience in the biotech/ pharma industry is preferable
- Minimum 5 years' experience with pharmacovigilance audits and inspections, of directly working in PV Quality and/or PV compliance function
- Knowledge of the activities related to the Affiliate PV sector
- Experience in working in or with QA function
- Ability to develop innovative, value-add solutions to problems and issues of a complex nature

**Our Benefits**:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

**About CSL Seqirus**:
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

**We want CSL Seqirus to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

**Do work that matters at CSL Seqirus**:
Watch our 'On the Front Line' video to learn more about CSL Seqirus