QMS - Consultant

Overview

We are seeking an experienced Quality Systems Manager to lead and continuously improve the Quality Management System (QMS) within a GMP-regulated pharmaceutical environment. This role will be responsible for ensuring compliance with global regulatory requirements while driving quality excellence across manufacturing, laboratory, supply chain, and support functions.

The successful candidate will act as the subject matter expert for quality systems, partnering with site and global stakeholders to strengthen compliance, inspection readiness, and operational effectiveness.

Key Responsibilities

• Manage and maintain the site's Quality Management System in accordance with EU GMP, FDA, ICH, and company quality standards.
• Oversee key quality processes including:
  • Deviations
  • CAPA Management
  • Change Control
  • Risk Management
  • Complaint Handling
  • Non-Conformances
  • Training Compliance
  • Document Control
• Lead quality system investigations and ensure timely closure of quality events.
• Monitor quality metrics and KPIs, identifying trends and driving continuous improvement initiatives.
• Support internal audits, supplier audits, customer audits, and regulatory inspections.
• Ensure ongoing inspection readiness and coordinate responses to audit observations.
• Provide guidance and training to cross-functional teams on GMP requirements and quality system processes.
• Collaborate with Manufacturing, Engineering, Validation, QC, Supply Chain, and Regulatory Affairs teams.
• Support implementation and optimisation of electronic Quality Management Systems (eQMS).
• Drive harmonisation and standardisation of quality processes across multiple sites where applicable.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, Engineering, or a related discipline.
• 5+ years of Quality Assurance or Quality Systems experience within the pharmaceutical or biotechnology industry.
• Strong knowledge of EU GMP regulations and pharmaceutical quality systems.
• Proven experience managing deviations, CAPAs, investigations, and change controls.
• Experience supporting regulatory inspections and audit programmes.
• Familiarity with electronic QMS platforms such as Veeva, TrackWise, MasterControl, or similar.
• Excellent stakeholder management and communication skills.
• Ability to influence cross-functional teams within a regulated manufacturing environment.

Preferred Experience

• Sterile manufacturing, biologics, vaccines, ATMP, or API production experience.
• Multi-site or global quality systems exposure.
• Experience leading quality improvement or quality transformation programmes.
• Knowledge of Data Integrity, Quality Risk Management, and Annex 1 requirements.