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🇬🇧 United Kingdom Corridor 🛡️ Verified Employer Direct Placement

Quality Operations Specialist

🏢 hVIVO Services Limited 📍 London, England 💼 Company - Public
Currency:
£22,021 - £29,250
£1,835 - £2,438 / mo
Verified Corporate Employer (Authorized Corporate Employer)

This vacancy is published by an accredited employer with authorized corporate payroll and standard compliance adherence.

Transatlantic Cost of Living & Purchasing Power Benchmark

Verified Analytics
Location Base
London, England
Tier-1 UK Economic Zone
Est. Take-Home Pay
68% - 74% (After PAYE & NI)
Single tax filer baseline
Transatlantic Parity
1.0 GBP ≈ $1.28 USD Living Standard
Direct corporate benchmark

Position Overview & Specifications

Overview:
We are looking for an experienced Quality Operations Specialist to join our QA team here at hVIVO. The role is to be responsible for the management of QMS Documents, provide quality advice and support in relation to Policies, SOPs, and Master Forms as well as the management for eQMS (electronic quality document management system) system.

Additionally, the role is responsible for leading and having oversight of the Management of the Regulatory Archives (Paper and Electronic) across all hVIVO sites to ensure compliance with regulatory standards and guidelines.

Main Responsibilities:
The main responsibilities for this role are;
  • Nominated Company Archivist, Oversight of management of the Archive;
  • System Owner for eArchive system;
  • Implement the Regulatory Archiving strategy;
  • Monitor and analyse regulations and guidance related to regulatory archiving and implement changes to hVIVO procedures;
  • Act as a source of advice and guidance on QMS document such as SOPs, policies and archive related quality issues;
  • Day to day running of the eQMS system with support from QA associate(s) where company Policies, Standard Operating Procedures, and Master Forms, etc and CAPAs are managed;
  • Implement processes for efficient creation, review and approval of documents within the eQMS systems.
  • Training Operations on eQMS, SOP management and Archiving
  • Provide assistance / support with Regulatory Training
  • Support QA team with external client audits and Inspections
  • Oversee the management and implement continual process improvement of hVIVO systems
  • Lead cross functional and interdivisional/ departmental projects to improve compliance and quality
Skills & Experiences:
We are looking for individuals who have the following skills and experience.

  • Demonstrated experience of working in a GCP/GCLP QA environment
  • Experience in all aspects of regulatory archiving in a CRO or pharmaceutical environnment
  • Experience of managing multi-site archives
  • Demonstrated experience of SOP management of clinical trials
  • Ability to work with all levels of stakeholders in the business
  • Degree or equivalent in science or relevant subject/experience
  • Ability to take initiative and focus on deliverying robust customer service out to the business.
If you feel you have the relevant skills and experience, please apply online.
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Candidate Selection & Onboarding Process

1

Application & Resume Screening

Submit your tailored CV/Resume directly to the talent acquisition portal.

2

Technical & Competency Interviews

Virtual interviews with the hiring manager and multidisciplinary team.

3

Formal Offer & Benefits Negotiation

Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.

4

Onboarding & Corporate Integration

Equipment provisioning, team orientation, and commencement of duties.

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Hiring Organization
hVIVO Services Limited

Apply for this Position

Location: London, England
Eligibility: Verified Employer Direct Placement
Schedule: Company - Public
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