QA MES Specialist

Quality Leader, Manufacturing Execution Systems

GSK is seeking a Quality Leader to lead quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. This role will partner with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness.

Responsibilities include:

• Leading MES quality activities including system configuration reviews, electronic batch record checks, and system change control support.
• Reviewing MES-generated records and reports to confirm completeness, data integrity, and compliance with procedures.
• Supporting investigations of deviations linked to MES or digital systems. Performing root cause analysis and tracking corrective actions.
• Partnering with validation and IT to ensure MES changes link to DQ/IQ/OQ/PQ or equivalent validation steps and documentation.
• Coaching manufacturing and lab teams on good documentation practices, electronic record keeping, and system use on the shop floor.
• Maintaining inspection-ready MES records and contributing to quality KPI trending and continuous improvement initiatives.
• Supporting readiness for internal and external audits, providing clear documentation and acting as a subject matter contributor during inspections.
• Managing supplier and third-party quality expectations for MES vendors and integrators, ensuring timely resolution of issues.

Basic qualifications include:

• Bachelor’s degree in a technical, scientific, or quality-related field, or equivalent experience.
• 2+ years experience in quality, manufacturing, or digital systems within a regulated life sciences environment.
• Experience with MES, electronic batch records, or other manufacturing execution or electronic quality systems.
• Experience supporting change control, deviations, CAPA, or document management in a regulated environment.

Preferred qualifications include:

• Bachelor’s degree in engineering, life sciences, information systems, or a related field.
• Experience with MES implementation, configuration, or validation in pharma or biotech.
• Understanding of DQ/IQ/OQ/PQ or equivalent validation lifecycle and how it ties to quality systems.
• Experience with electronic document management systems or quality management software.
• Formal training in root cause analysis methods or investigation techniques.
• Ability to coach and influence operational teams and to present technical information clearly.
• Strong written and verbal communication skills and the ability to work across functions.
• Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including data integrity principles.

This role requires on-site presence for hands-on MES support, validation activities, and shop-floor coaching. Minimum 4 days weekly on site.

To apply, please tell us how your skills and experience match this role. We welcome applicants from all backgrounds and are committed to an inclusive workplace where everyone can succeed.