MES Quality Assurance Lead — GxP & Digital Systems

Regulatory Jobs; Pennsylvania; Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

GSK is seeking an experienced Quality Assurance professional to provide operational oversight of MES workflows and electronic batch records in a regulated manufacturing environment. You will partner with manufacturing, IT, and quality teams to keep processes compliant and data trustworthy, driving CAPA, validation, and change-control activities.

The role emphasizes coaching, integrity, and proactive quality culture, with hands‑on learning and visible impact as the company unites science,

Formación

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.
• Minimum 3 years' experience in regulated industry preferably in Quality Assurance.
• Must have prior MES implementation experience.
• Requires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
• Experienced with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• Training and work experience in DMAIC root cause analysis methodology.
• Must have 1 + year of hands‑on experience with Good Manufacturing Practices and Good Documentation Practices.

Responsabilidades

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.
• Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation
• Review and approve creation and/or updates to master data: Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi
• Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi
• Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi
• GxP, DI, Business Continuity Risk Assessments, PI inventory
• IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable). Audit Trail Reviews
• Develop/Approve MES LSOPs and associated child documents
• Provide review, initial impact approval, and final approval of devations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
• Role model the GPS standards and foster a ‘Quality Starts With Me’ culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non‑compliance can have on product quality and patient safety.
• Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.
• Lead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow-up. Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.
• Support inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.
• Monitor MES‑related quality KPIs and trends and recommend process or system improvements.

Conocimientos

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

Educación

Bachelor’s degree in Life Sciences / Biology / Chemical Engineering

Herramientas

LIMS

Electronic batch records

Descripción del empleo

GSK is seeking an experienced Quality Assurance professional to provide operational oversight of MES workflows and electronic batch records in a regulated manufacturing environment. You will partner with manufacturing, IT, and quality teams to keep processes compliant and data trustworthy, driving CAPA, validation, and change-control activities.

The role emphasizes coaching, integrity, and proactive quality culture, with hands‑on learning and visible impact as the company unites science,