QA Validation Manager
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Greater Sheffield
Flexibility required to travel to other UK sites
Role Purpose:
The QA Validation Manager will act as the critical interface between Quality Assurance and Operations, providing QA leadership, governance, and oversight of all validation activities across the business.
This newly created role establishes validation ownership within QA, ensuring validation activities are compliant, inspection‑ready, and aligned with regulatory, quality, and business expectations.
The role carries a strong sterile and aseptic manufacturing focus, supporting new product introductions, QC projects, and facility‑based projects across multiple UK sites.
Key Responsibilities:
QA Validation Leadership & Governance
- Act as the QA lead and approval authority for validation activities, ensuring compliance with GMP, Annex 1, MHRA, and internal quality standards.
- Establish and maintain QA oversight of validation strategy, including process, cleaning, equipment, utilities, computer systems, and facility validation.
- Review, approve, and assess risk related to validation master plans, protocols, reports, and deviations.
QA–Operations Interface
- Serve as the primary QA point of contact for Operations‑led validation activities, ensuring effective collaboration without duplication of effort.
- Challenge and support Ops validation activities from a quality and compliance perspective, acting as the independent QA voice.
- Support resolution of validation‑related deviations, CAPAs, and change controls.
Project Support (QC, NPI, Facility)
- Provide QA validation input into:
- QC projects
- New Product Introduction (NPI) projects
- Facility, equipment, and infrastructure projects
- Ensure validation requirements are built into project plans from initiation through execution and close‑out.
- Participate in cross‑functional project teams alongside QC, Engineering, Operations, and Regulatory.
Sterile / Aseptic Oversight
- Provide QA oversight for validation activities in sterile and aseptic manufacturing environments.
- Ensure Annex 1 expectations are appropriately interpreted and embedded into validation and qualification activities.
- Support inspection readiness and regulatory interactions related to sterile processing and validation.
People Management
- Provide line management, coaching, and development for 4 staff members.
- Set clear objectives, priorities, and performance expectations aligned with quality and project delivery goals.
Continuous Improvement & Systems
- Support the development and maintenance of validation and QA SOPs, templates, and standards.
- Contribute to inspection readiness, internal audits, and regulatory inspections. xwzovoh
- Identify opportunities to improve validation processes, documentation quality, and QA–Ops ways of working.
Skills & Experience Required:
Essential-
- Strong experience in GMP validation within a QA environment
- Background in sterile and aseptic manufacturing
- Experience reviewing and approving validation documentation from a QA perspective
- Practical experience with deviations, CAPAs, and change control related to validation
- People management or project leadership experience
- Willingness and flexibility to travel across multiple sites
- Confident communicator capable of influencing cross‑functional stakeholders
Desirable-
- Experience supporting QC, NPI, or facility‑based projects
- Previous involvement in regulatory inspections (MHRA or equivalent)
- Experience shaping or establishing QA validation frameworks or governance models
What This Role Offers:
- Opportunity to define and shape QA validation oversight in a growing, regulated environment
- High visibility role with direct access to the Head of Quality
- Exposure to varied projects across sterile operations, QC, facilities, and product development
- Clear people leadership responsibility and career progression potential