PV Systems and Processes Lead x2

CSL; Maidenhead; On-site; GBP 70,000 - 110,000; Full time

Job summary

CSL Maidenhead is seeking a PV Systems & Process Lead to ensure the global PV system remains compliant, inspection-ready, and continuously improved across GCSP, GRA, GMA, affiliates and commercial operations.

This senior role blends regulatory expertise with practical problem solving to identify systemic risks, drive CAPA, and lead cross-functional efforts to embed robust PV quality controls.

Qualifications

• Science or life sciences degree and significant pharma industry experience, especially PV or GxP QA.

Responsibilities

• Own the quality and compliance infrastructure underpinning CSL's PV system.
• Provide expert GVP guidance and translate regulatory changes into action.
• Lead deviations and non-compliance investigations including CAPA.
• Review documents for GVP compliance across GCSP, GRA, and GMA.
• Coordinate health authority and third-party PV audits regionally.
• Track quality indicators, identify trends, and escalate risks.
• Deliver PV quality training and share best practices across functions.
• Contribute to the long-term PV audit strategy aligned with GVP Module IV.

Skills

GVP regulations mastery

PV inspections management

CAPA development and tracking

Root cause analysis

Cross-functional influence

Communication and leadership

Education

Science or life sciences degree

Job description

PV Systems & Process Lead

Patient safety depends on pharmacovigilance systems that work - and work well. In this role, you'll be at the centre of keeping CSL's global PV system compliant, continuously improving, and inspection-ready across Global Clinical Safety & Pharmacovigilance, Global Regulatory Affairs, Global Medical Affairs, affiliates, and commercial operations.

PV Systems & Process Lead

Patient safety depends on pharmacovigilance systems that work - and work well. In this role, you'll be at the centre of keeping CSL's 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 You'll Do

You'll own the quality and compliance infrastructure that underpins CSL's 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

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

What You'll 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