# Quality R&D Operations Validation Lead

**Company**: GSK
**Location**: Ware
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK---Hertfordshire---Ware-RD/Quality-R-D-Operations----Validation-Lead_449499-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

The Quality R&D Operations Validation Lead provides Quality Assurance oversight across GSK’s UK Pharma R&D sites to ensure compliant validation, qualification, and operational quality activities.

The role works across Engineering, Facilities, Validation, R&D Operations, Scientific Functions, and outsourced service providers. Operating with a high degree of autonomy, you will provide expert guidance and risk-based decision-making on complex quality and compliance matters with regulatory and business impact.

Key areas of validation responsibility include; Equipment, Facilities and Utilities (as well as some focus on associated Computerised Systems / Automation).

**Key Responsibilities:**

- Manage complex cross-functional QA-related projects and programmes, ensuring delivery against defined scope, timelines, and quality aims (particularly in support of regulatory inspections, high-risk compliance activities, and business-critical initiatives).

- Act as a co-ordinator for complex quality initiatives, working with cross-functional stakeholders, tracking progress, managing risks and dependencies, and ensuring successful execution.

- Build strong relationships with internal stakeholders and external partners, acting as a primary contact for designated projects, programmes, or business areas.

- Drive continuous improvement initiatives to ensure delivery through structured systems.

**Travel:** Some travel between GSK’s UK R&D sites (Ware R&D, Stevenage, Harlow & Addenbrookes, Cambridge) will be required.

**About You:**

As this role is multi-faceted and includes liaising with a wide variety of on-site teams, you will be a self-motivated person who has experience of working in technical and/or validation roles within a complex working environment (e.g. a R&D or manufacturing site).

**Basic Qualifications:**

- BSc in relevant subject (e.g. Scientific, Technical or Engineering discipline) or equivalent.

- Relevant experience in Quality Assurance (QA) within a GMP-regulated pharmaceutical, biotechnology, or healthcare environment.

- Strong knowledge of GMP/GxP requirements and regulatory expectations for major countries.

- Proven experience providing quality oversight of validation and qualification activities for facilities, utilities, and equipment.

**Preferred Qualifications:**

- Experience of computerised systems validation would be helpful.

- Understanding of the application of phase appropriate GMP standards would be useful.

## Skills

### Required
- Data Integrity
- Detail-Oriented
- Digital Fluency
- GxP Regulations
- Influencing Without Authority
- Lean Management
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing

### Nice to have
- computerised systems validation
- phase appropriate GMP standards

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK---Hertfordshire---Ware-RD/Quality-R-D-Operations----Validation-Lead_449499-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)