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    • We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions…
    • Proven ability to lead deviation and CAPA management processes.
    • Patient safety depends on pharmacovigilance systems that work — and work well.
    • New entrants to the Civil Service will start their role on the salary band minimum of £46,160.
    • This is a full-time opportunity, on a permanent basis.
    • View all Medicines and Healthcare Products Regulatory Agency jobs - South Mimms jobs - Quality Assurance Manager jobs in South Mimms
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    • Build strong stakeholder relationships while maintaining auditor independence and the confidence to challenge constructively.
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    • This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and…
    • This person will maintain a Pharmacovigilance quality assurance programme to ensure that the pharmacovigilance system supporting VH products is compliant with…
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    • You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain…
    • Maintain and develop full regulatory compliance for medical device manufacturing under ISO 13485 and MHRA guidelines.
    • Implement, lead and continually improve the internal audit process, providing effective feedback to ensure audit readiness across the site at all times.
    • Act as the main point of contact for quality-related matters with customers, auditors, suppliers, and internal stakeholders.
    • This role is key to managing and delivering end-to-end internal audit and controls assurance engagements that enhance clients’ control environments and…
    • Ability to orchestrate, lead, and influence virtual teams, ensuring successful implementation of customer projects.
    • You will lead and deliver quality transformation initiatives, combining strong hands‑on expertise with a pragmatic, client‑focused consulting approach.
    • Trained and experienced lead auditor.
    • Maintaining auditor qualification and competency to the required levels.
    • Support delivery of team KPIs.
    • Experience within a medical device or healthcare manufacturing industry in a regulatory or quality role.
    • You will be responsible for a portfolio of cutting-edge…

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Job Post Details

Auditor - GVP - job post

CSL
(part of CSL)
2.9 out of 5 stars
Maidenhead SL6 8AA
Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Full-time

Location

Maidenhead SL6 8AA

Full job description

Quality in a globalized drug safety network is a matter of operational resilience as much as regulatory mandate. This role serves as a GVP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of safety data and compliance with legal and corporate standards. By conducting audits of our external partners and internal safety functions, you identify the findings and non-compliance trends that could impact the reliability of our pharmacovigilance system. We are looking for an experienced auditor who can navigate complex safety environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.


Main Responsibilities

  • Audit Execution: Conduct assigned external audits of pharmacovigilance vendors and service providers, as well as internal self-inspections of safety processes, systems, and affiliates (including Local/Regional Safety Officers (LSO/RSOs) activities).
  • Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to drug safety.
  • Trend Analysis: Identify non-compliance trends and systematic risks within the PV discipline, communicating these findings to line management and functional leads to support PV system health and protect the integrity of the PSMF documenting it.
  • Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules), and applicable global and local regulatory requirements..
  • Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance.


Position Qualifications & Experience

  • Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline.

  • Professional Experience: Quality Assurance experience within a GVP-regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.

  • Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the pharmacovigilance discipline.

  • Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external stakeholders across different regions.

  • Working Knowledge of:

  • ICH E2D(R1), E2A, E2B(R3), E2C(R2), and E2F Guidelines

  • 21 CFR Part 314.80 (for drugs), 21 CFR Part 600 Subpart D (for biologics) and 21 CFR Part 4 (Combination product/duplicate reporting prevention)

  • Directive 2001/83/EC (as amended)

  • Regulation (EC) No 726/2004

  • Commission Implementing Regulation (EU) No 520/2012

  • EMA GVP Modules (I–XVI + product/population-specific modules)

  • Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.

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