Compliance Specialist

About the role

You will help ensure our manufacturing and supply operations meet quality and regulatory expectations. You will lead investigations of unplanned events, drive corrective actions, and support change controls. You will work with manufacturing, quality, engineering, and other partners. We value clear problem solvers who act with integrity, communicate simply, and enjoy improving systems. This role gives you growth, meaningful impact, and a chance to contribute to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities

• Lead investigations of deviations and unplanned events, using structured root cause analysis.
• Own and drive corrective and preventive actions (CAPA) to timely resolution with cross-functional partners.
• Prepare clear investigation reports and present findings to operations, quality, and management.
• Manage change controls and update operational documents such as SOPs, batch records, and training materials.
• Support continuous improvement initiatives to reduce repeat events and improve right-first-time performance.
• Train and coach staff on compliance to strengthen a culture of compliance.
• Perform root cause analysis which may require facilitation of cross-functional teams to investigate deviations and determine robust corrective actions, lead problem solving, and support recurrent and complex deviations using DMAIC.
• Timely completion of Engineering quality system action plans, including writing, revising, or coordinating change controls, SOPs, audits, and training documentation.
• Represent the Engineering department at site change control meetings.
• Prepare and track change controls to make improvements outside of deviations.
• Assess Global QMS (Quality Management System), Engineering, and EHS standards in creation and revision of Engineering SOPs to align with global requirements.
• Track, trend, and evaluate Engineering misalignments and work to determine root causes, including tracking and trending progress of CAPAs (EHS and GMP) using a routine reporting system.
• Interact and coordinate with appropriate personnel including manufacturing, Supply Chain, Engineering, QA/QC, regulatory, etc.
• Communicate immediately with QA, Operations, Supply Chain, and EHS management for all Engineering discrepancies that impact product quality or safety.
• Develop internal GMP and EHS audit schedules (including areas to be audited) on a yearly basis.
• Interact with external regulatory authorities as needed during routine and non-routine audits.
• Perform all job responsibilities in compliance with GSK safety procedures and all applicable EHS regulations, SOPs, and industry practices.
• Monitor process health through various governances, scorecards, data trending, etc., and problem solve or escalate issues when out of acceptable state.

Requirements

• B.S or B.A in a technical discipline, preferably in Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering, or Pharmacy. Degree in another discipline is acceptable if sufficient technical depth has been achieved from professional experience.
• Minimum of 3 years of pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role.
• Experience performing investigations, root cause analysis, or working in a compliance role.
• Familiarity with quality system elements such as deviations, CAPA, change control, and document control.

Preferred Qualifications

• Hands-on experience with SAP or similar quality/event management systems.
• Proficiency with Microsoft Office, especially Excel for data tracking and basic analysis.
• Familiarity with formal RCA tools (5 Whys, fishbone, FMEA) and continuous improvement methods.
• Experience supporting audits or interacting with regulatory authorities.
• Experience delivering training or coaching non-quality staff on compliance processes.

Benefits

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

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• Emergency Response
• Financial Acumen
• GxP Regulations
• Lean Management
• Manufacturing Processes
• Problem Solving
• Production Management
• Project Coordination
• Quality Compliance
• Regulatory Compliance
• Risk Awareness
• Site Operations