PV Systems and Processes Lead x2

PV Systems & Process Lead

Patient safety depends on pharmacovigilance systems that work and work this role youll be at the centre of keeping CSLs global PV system compliant continuously improving and inspection-ready across Global Clinical Safety & Pharmacovigilance Global Regulatory Affairs Global Medical Affairs affiliates and commercial operations.

This is a role for someone who thrives at the intersection of regulatory expertise and practical problem-solving someone who can spot a systemic compliance risk build the relationships to address it and drive the change that makes it stick.

What youll do

Youll own the quality and compliance infrastructure that underpins CSLs PV system. Day-to-day that means:

• Providing expert GVP and PV legislation guidance across the organisation and ensuring that regulatory changes translate into timely concrete action
• Leading investigation and resolution of deviations and non-compliances including root cause analysis CAPA development and effectiveness tracking
• Reviewing procedural documents across GCSP GRA and GMA for GVP compliance
• Serving as the primary inspection coordinator for health authority and third-party PV audits in your region from readiness planning through to CAPA close-out
• Tracking quality and performance indicators identifying trends and escalating risks appropriately
• Delivering PV quality training and sharing best practices across functions and affiliates

Youll also contribute to the broader audit programme and help shape the long-term PV audit strategy in line with GVP Module IV.

What youll bring

• A science or life sciences degree (or equivalent through experience) plus significant experience in the pharmaceutical industry mainly in PV or GxP Quality Assurance
• Hands-on experience managing regulatory inspections and PV audits
• Strong command of GVP regulations ICH GCP and relevant international requirements
• Proven ability to lead deviation and CAPA management processes
• The communication and leadership skills to influence across functions regions and seniority levels

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus