PV Systems and Processes Lead

CSL Plasma Inc.; Maidenhead; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

CSL Seqirus is seeking a PV Systems & Process Lead in Maidenhead to keep CSL's global PV system compliant, continuously improving, and inspection-ready across GCSP, GRA, and GMA affiliates and commercial operations. This hybrid role entails three days on-site at the Maidenhead office.

You will own the quality and compliance infrastructure, provide expert GVP guidance, lead investigations and CAPA, coordinate health authority audits, monitor KPIs, and deliver PV training while shaping the

Qualifications

• Science or life sciences degree and substantial pharma industry experience in PV or GxP QA.
• Hands-on regulatory inspections and PV audits experience.
• Strong command of GVP, ICH GCP and international PV requirements.
• Proven ability to lead deviation and CAPA management processes.
• Excellent communication and leadership to influence across regions and seniority.

Responsibilities

• Own the quality and compliance infrastructure underpinning CSL's PV system.
• Provide expert GVP guidance and translate regulatory changes into actions.
• Lead investigations of deviations, root-cause analyses, CAPA development and tracking.
• Coordinate health authority and third-party PV audits from readiness to CAPA close-out.
• Track quality indicators, identify trends, and escalate risks as required.
• Deliver PV quality training and share best practices across functions.

Skills

PV governance

Regulatory inspection experience

GVP & ICH GCP

CAPA management

Cross-functional influence

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.

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.

This position is to be hybrid (3 days a week on-site) at our office in Maidenhead.

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

About CSL Seqirus

CSL Seqirus is part of 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. 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our 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 https://www.csl.com/careers/inclusion-and-belonging

Equal 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 https://www.csl.com/accessibility-statement.

Watch our 'On the Front Line' video to learn more about CSL Seqirus

CSL is an Equal Opportunity Employer.

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