PV Systems and Processes Lead

Meeveem Limited; Maidenhead; On-site; GBP 65,000 - 85,000; Full time

Benefits offered by this job

Health and well-being benefits

Job summary

Meeveem Limited is seeking a PV Systems & Process Lead to ensure compliance within CSL's pharmacovigilance systems. You'll manage regulatory inspections, lead risk assessments, and ensure swift adaptation to regulatory changes for effective global compliance.

A degree in a science field combined with extensive pharmaceutical industry experience is required. Candidates should demonstrate leadership in deviation management and have strong communication skills for cross-functional collaboration. Join a company dedicated to patient safety and innovation in the healthcare sector.

Qualifications

• Significant experience in the pharmaceutical industry, mainly in pharmacovigilance or GxP quality assurance.
• Hands-on experience managing regulatory inspections and PV audits.
• Strong command of GVP regulations, ICH GCP, and relevant international requirements.

Responsibilities

• Lead and ensure GVP compliance across the organization.
• Investigate and resolve deviations and non-compliances.
• Serve as primary inspection coordinator for health authority audits.

Skills

Regulatory compliance expertise

Problem-solving skills

Communication skills

Leadership skills

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.

What you’ll do

• Providing expert GVP and PV legislation guidance across the organization, 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.

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.

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.