PV Systems and Processes Lead

Biopharma Careers; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

CSL Seqirus seeks a PV Systems & Process Lead to own the quality and compliance infrastructure underpinning our PV system. You will provide expert GVP guidance, lead deviation investigations, and coordinate health authority PV audits across regions. A science degree and hands-on PV/GxP QA experience are essential.

You'll drive CAPA processes, review key procedures for GVP compliance, and train teams in PV quality practices to support inspection readiness and continuous improvement.

Qualifications

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

Responsibilities

• Own the quality and compliance infrastructure underpinning CSL's PV system.
• Provide expert GVP and PV guidance across the organisation, translating changes into action.
• Lead investigations of deviations and non-compliances with RCA and CAPA.
• Review GCSP, GRA, and GMA procedures for GVP compliance.
• Coordinate health authority PV audits and CAPA closure.
• Track quality metrics, identify trends, escalate risks.
• Deliver PV quality training and share best practices.

Skills

PV QA experience

Regulatory inspections

GVP knowledge

GxP Quality Assurance

CAPA management

Leadership & communication

Education

Science 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 your 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, 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