Senior QA Documentation Specialist

GSK is a global biopharma company uniting science, technology, and talent to get ahead of disease together. We manufacture and supply high-quality medicines and vaccines, delivering 1.7 billion packs of medicines and 409 million vaccine doses in 2024. Our supply chain is vital to bringing innovations to patients quickly and efficiently, leveraging smart manufacturing technologies including robotics, digital solutions, and artificial intelligence.

About the role

The Senior QA Documentation Specialist provides advanced oversight, governance, and continuous improvement of cGMP quality systems supporting vaccine manufacturing at the Marietta site. This role serves as a recognized subject matter expert (SME) for Documentation systems, with accountability for system performance, regulatory compliance, inspection readiness, and data integrity. The specialist evaluates quality risks, leads complex investigations and CAPAs, and provides quality decision-making for their assigned system while partnering cross-functionally to ensure robust and effective quality systems.

Responsibilities

• Act as site-level system owner or SME for assigned cGMP quality systems, ensuring Documentation Systems procedures/processes are robust and compliant with regulatory and global requirements.
• Own Documentation system performance, including KPI development, trend analysis, escalation, and action planning.
• Provide risk-based quality assessments and recommendations to site leadership and cross-functional stakeholders.
• Lead inspection readiness activities, including system defense, data package preparation, inspector interaction, and response authorship.
• Execute training activities on cGMP quality systems as a Qualified Trainer.
• Serve as QA liaison with site operations and global quality organizations to resolve systemic quality issues.
• Mentor and coach site individuals, providing technical guidance and system knowledge transfer.
• Act as backup for Documentation Coordinator and Quality Manager when applicable.
• Lead quality system continuous improvement and simplification initiatives with measurable compliance or efficiency outcomes.
• Complete all activities in compliance with cGMPs, internal procedures, EHS requirements, and regulatory standards.

Requirements

• Bachelor's degree in a scientific, engineering, pharmacy, or related discipline, or equivalent experience.
• 5+ years of pharmaceutical or regulated industry experience within a Quality organization, with demonstrated ownership of quality systems.
• Experience supporting regulatory inspections and authoring or contributing to inspection responses.
• Experience with data trending, KPI development, and management review reporting.
• Technical understanding of industry and science practices related to the business.

Preferred Qualifications

• Master's degree in science or business discipline or an additional BS.
• Strong ability to influence cross-functional stakeholders and drive compliance without direct authority.
• Advanced knowledge of cGMP regulations and quality system governance.
• Demonstrated application of quality risk management principles.
• Strong written and verbal communication, including inspection-facing interactions.
• Ability to mentor others and act as an informal technical leader.
• Proficiency with electronic quality management systems (eQMS) and data integrity controls.

Work Model

This role is hybrid. You will be on site regularly and have flexibility to work remotely. Occasional travel to supplier sites and audits is expected.

Skills

• 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

Benefits

Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

GSK values transparency, respect, integrity, evidence-based decision-making, and an inclusive environment where everyone can thrive. We are committed to improving quality for patients and welcome people from all backgrounds.