PV Systems and Processes Lead x2 in Maidenhead

PV Systems and Processes Lead x2 in Maidenhead

Maidenhead Full-Time 60000 - 80000 £ / year (est.) No working from home possible
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At a Glance

  • Tasks: Lead pharmacovigilance systems to ensure patient safety and compliance across global operations.
  • Company: Join CSL Seqirus, a leading influenza vaccine provider with a commitment to innovation.
  • Benefits: Enjoy comprehensive health coverage, retirement plans, and wellness programmes.
  • Other info: Dynamic role with opportunities for professional growth and development.
  • Why this job: Make a real impact on global health by ensuring safety in pharmaceutical practices.
  • Qualifications: Science degree and experience in pharmacovigilance or GxP Quality Assurance required.

The predicted salary is between 60000 - 80000 £ per year.

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, 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 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 Gx P 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, one of the largest influenza vaccine providers in the world, and a major contributor to the prevention of influenza globally.

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.

Benefits

Our benefits include comprehensive health coverage, retirement savings plans and wellness programs. Learn more about our benefits.

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

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PV Systems and Processes Lead x2 in Maidenhead employer: Energy Jobline ZR

World Wide Technology (WWT) is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for a Programme Director in London. With a strong focus on employee growth, WWT offers opportunities to lead cutting-edge automation projects while working in a hybrid environment that promotes work-life balance. The company values transparent communication and client-first service, ensuring that employees are empowered to drive meaningful outcomes and develop their skills in a supportive atmosphere.

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Contact Details:

Energy Jobline ZR Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land PV Systems and Processes Lead x2 in Maidenhead

Unlock Networking Opportunities

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Tailor Your Approach

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We think you need these skills to ace PV Systems and Processes Lead x2 in Maidenhead

GVP Regulations
ICH GCP
Pharmacovigilance (PV)
GxP Quality Assurance
Regulatory Compliance
Deviation Management
CAPA Development

Some tips for your application 🫡

Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Energy Jobline ZR!

Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Energy Jobline ZR that you're not just a fit for the job but also a safety-conscious candidate!

Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Energy Jobline ZR!

Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Energy Jobline ZR, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.

How to prepare for a job interview at Energy Jobline ZR

Understand the Science

Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Energy Jobline ZR that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.

Showcase Relevant Experience

If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.

Know Their Products

Take some time to familiarise yourself with Energy Jobline ZR’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.

Be Ready for Regulatory Scenarios

In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.