It auditor Work, Jobs in Maidenhead, Brk (with Salaries)

Auditor - GCP
CSL Seqirus —Maidenhead
- Full-time
- Up to 50% travel
- Analysis skills
- Bachelor's degree
6h
Technical & Compliance Officer
The Fish Society —Guildford
- £34,000 a year
- Full-time
- Bachelor's degree
- Quality control
- In-person
Quick apply
Auditor - GVP
CSL Seqirus —Maidenhead
- Full-time
- Up to 50% travel
- Analysis skills
- Bachelor's degree
Night Auditor
Crowne Plaza Gerrards Cross —Beaconsfield
- Full-time
- Customer service
- English
- Hotel
- Employee assistance programme
- Bereavement leave
Quick apply
Senior Cloud Billing Analyst
Softcat —Marlow
- Hybrid work
- Analysis skills
- Leadership
- Communication skills
- Flexible schedule
Information Security Officer
BAM UK & Ireland —Hemel Hempstead
- Monday to Friday
- Bachelor's degree
- Travel
- Organisational skills
Internal Auditor - Not For Profit - Central London
Hanami International —London
- £40,000 - £45,000 a year
- Full-time
- Hybrid work
- Analysis skills
- Organisational skills
- Communication skills
Quick apply
Audit and Governance Committee Independent Members
Royal Borough of Windsor and Maidenhead —Maidenhead
- £650 a week
Quality Auditor
Hypnos Beds —Princes Risborough
- £13.35 an hour
- Full-time
- Analysis skills
- Continuous improvement
- Quality control
- Health & wellbeing programme
- Employee discount
Quick apply
9d
Management Systems Auditor (North & West London)
BSI —Slough
- Time management
- Annual leave
Procurement Quality Control Supervisor
Kiwa —Woking
- Full-time
- Engineering
- Quality control
- Travel
Information Security Officer
Arvato —Datchet
- £38,000 - £48,000 a year
- Full-time
- Hybrid work
- Communication skills
- Annual leave
- Employee discount
Internal Operations Auditor Associate (Lettings & Legislation)
LRG —Camberley
- Remote
- Administrative experience
- Communication skills
Quick apply
Quality Engineer
QinetiQ —Farnborough
- £47,700 - £53,000 a year
- Full-time
- Continuous improvement
- Communication skills
- Employee discount
Quality Assurance & Regulatory Affairs Executive - Maternity Cover
TensCare Ltd —Epsom
- £35,000 - £42,500 a year
- Temporary
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
- Profit sharing
- Work from home
Quick apply
Assistant Auditor
L. BENNETT & SON LIMITED —St Albans
- Microsoft Word
- Customer service
- Continuous improvement
SAP Basis Automation Engineer
Avantra —Richmond
- Remote
- Travel
- Communication skills
Finance Assistant
LRG —Camberley
- Hybrid work
- Microsoft Word
- Communication skills
Quick apply
Director, Finance Business Partnering – International Commercial & Pandemic
CSL Seqirus —Maidenhead
- Full-time
- Business development
- Team management
- Leadership
Pub & Restaurant Stocktaker - Guildford
nGeneration —Guildford
- £26,500 - £28,500 a year
- Weekend availability
- Hospitality
- Bar
- Customer service
Quick apply

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Auditor - GCP

CSL Seqirus -
Maidenhead

Apply Now

Job details

Full-time
6 hours ago

Qualifications

Clinical research
Stakeholder collaboration
Stakeholder liaison
Compliance audits
Analysis skills
Bachelor's degree
Clinical audit participation
Clinical audit
Clinical compliance monitoring
Good Clinical Practice (GCP)
Communication skills
Internal quality assurance
Good Clinical Practice (ICH-GCP) guidelines

Full job description

Entity: CSL Seqirus

Job Category: Quality

Job Family: Clinical Quality

Job Type: Full Time

Location: Maidenhead, Berkshire, United Kingdom

Employer Reference: R-284380

Job Description

Quality in clinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards. By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. We are looking for an experienced auditor who can navigate complex clinical 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 clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
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 trial conduct and data integrity.
Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Position Qualifications & Experience

Academic Background: BS degree in a relevant biological science, science, or related discipline
Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
Working Knowledge of:
- ICH E6 (R3) Guideline
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- 21 CFR Part 50 – Protection of Human Subjects (Informed Consent)
- 21 CFR Part 312 – Investigational New Drug Application
- 21 CFR Part 812 – Investigational Device Exemptions
- Clinical Trials Regulation (CTR) (EU) No 536/2014
- Directive 2001/20/EC (Clinical Trial Directive)
- Directive 2005/28/EC (GCP Directive)
- Directive 2001/83/EC (Annex I)
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.

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.

Apply Now

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Job Description

About CSL Seqirus

Our Benefits

You Belong at CSL

Equal Opportunity Employer

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