Senior QA Documentation Specialist

GSK • Marietta, PA

1d • Hybrid

About The Position

The Senior QA Documentation Specialist is responsible for 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 increased accountability for system performance, regulatory compliance, inspection readiness, and data integrity. The Senior QA Documentation Systems Specialist provides evaluates quality risks, leads complex investigations and CAPAs, provides quality decision‑making for their assigned system. The individual partners cross‑functionally to ensure quality systems are robust, effective, and aligned with global and regulatory expectations.

Requirements

• Bachelor’s degree in a scientific, engineering, pharmacy or related discipline, or equivalent experience.
• 5+ years 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 & science practice related to business.

Nice To Haves

• 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

Responsibilities

• Acts as site-level system owner or SME for assigned cGMP quality systems, ensuring the Documentation Systems procedures/processes are robust and compliant with Regulatory and global requirements.
• Owns Documentation system performance, including KPI development, trend analysis, escalation, and action planning.
• Provides risk‑based quality assessments and recommendations to site leadership and cross‑functional stakeholders.
• Leads inspection readiness activities, including system defense, data package preparation, inspector interaction, and response authorship.
• Responsible for execution of training activities on cGMP quality systems (Qualified Trainer).
• Serves as QA liaison with site operations and global quality organizations to resolve systemic quality issues.
• Mentors and coaches site individuals, providing technical guidance and system knowledge transfer.
• Responsible for backup roles for Documentation Coordinator and Quality Manager when applicable.
• Leads quality system continuous improvement and simplification initiatives with measurable compliance or efficiency outcomes.
• Completes all activities in compliance with cGMPs, internal procedures, EHS requirements, and regulatory standards

Benefits

• GSK US Benefits Summary

What This Job Offers

• Job Type: Full-time
• Career Level: Senior