GSK LLP
Compliance Specialist
This Compliance Specialist role is designed to support GSK's key investment initiative at the Marietta site (DP Project) by helping expand drug product capacity. The position plays an essential part in ensuring quality and compliance during the site's growth, driving change control, deviation investigations, and the implementation of corrective actions to maintain high standards throughout the expansion process. In addition, this role will not only lead and coordinate end-to-end (E2E) activities for the parts of project but will also provide support throughout the installation, qualification, validation, and Process Performance Qualification (PPQ) phases. The Compliance Specialist will help the team organize all deliverables to ensure a successful regulatory filing. Key Responsibilities
Lead Change Control for NPI
Manage end-to-end change control activities related to new facility startup and new product introduction, ensuring timely approvals and implementation within the quality system. Risk & Impact Evaluation
Facilitate cross-functional risk assessments to evaluate impacts of facility, equipment, utility, and process changes on product quality, patient safety, and regulatory filings. Validation & Documentation Oversight
Ensure change controls are linked to validation deliverables (DQ/IQ/OQ/PQ, cleaning validation, process validation) and that documentation is inspection-ready. Regulatory & Compliance Alignment
Support preparation of regulatory submissions and health authority interactions by ensuring change records reflect compliance with FDA, EMA, ICH, and other global requirements. Cross-Functional Collaboration
Partner with engineering, manufacturing, QC/QA, regulatory, and supply chain to integrate change controls into project plans for seamless facility and product introduction. Lead cross functional team to investigate deviations during media challenge, PPQ. Initiate deviations using a qualified system such as SAP and prepare clear, concise reports from outcome of investigations. Perform root cause analysis, using RCA tools. Determine robust corrective actions and/or commitments. Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc. For RCA or per business needs, review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents. Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives. Basic Qualifications
Bachelors degree in a technical or engineering discipline. 1+ years pharmaceutical experience change control, investigation manufacturing deviations either in a QA or manufacturing role; preferably in Biologics or Vaccine Secondary Manufacturing. Preferred Qualifications
Demonstrated problem solving and investigational skills. The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation. Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment. Able to maintain attention to detail while executing multiple tasks. Able to perform job duties with minimal supervision. Sense of urgency, flexibility and accountability. Intermediate computer skills required.
This Compliance Specialist role is designed to support GSK's key investment initiative at the Marietta site (DP Project) by helping expand drug product capacity. The position plays an essential part in ensuring quality and compliance during the site's growth, driving change control, deviation investigations, and the implementation of corrective actions to maintain high standards throughout the expansion process. In addition, this role will not only lead and coordinate end-to-end (E2E) activities for the parts of project but will also provide support throughout the installation, qualification, validation, and Process Performance Qualification (PPQ) phases. The Compliance Specialist will help the team organize all deliverables to ensure a successful regulatory filing. Key Responsibilities
Lead Change Control for NPI
Manage end-to-end change control activities related to new facility startup and new product introduction, ensuring timely approvals and implementation within the quality system. Risk & Impact Evaluation
Facilitate cross-functional risk assessments to evaluate impacts of facility, equipment, utility, and process changes on product quality, patient safety, and regulatory filings. Validation & Documentation Oversight
Ensure change controls are linked to validation deliverables (DQ/IQ/OQ/PQ, cleaning validation, process validation) and that documentation is inspection-ready. Regulatory & Compliance Alignment
Support preparation of regulatory submissions and health authority interactions by ensuring change records reflect compliance with FDA, EMA, ICH, and other global requirements. Cross-Functional Collaboration
Partner with engineering, manufacturing, QC/QA, regulatory, and supply chain to integrate change controls into project plans for seamless facility and product introduction. Lead cross functional team to investigate deviations during media challenge, PPQ. Initiate deviations using a qualified system such as SAP and prepare clear, concise reports from outcome of investigations. Perform root cause analysis, using RCA tools. Determine robust corrective actions and/or commitments. Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc. For RCA or per business needs, review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents. Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives. Basic Qualifications
Bachelors degree in a technical or engineering discipline. 1+ years pharmaceutical experience change control, investigation manufacturing deviations either in a QA or manufacturing role; preferably in Biologics or Vaccine Secondary Manufacturing. Preferred Qualifications
Demonstrated problem solving and investigational skills. The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation. Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment. Able to maintain attention to detail while executing multiple tasks. Able to perform job duties with minimal supervision. Sense of urgency, flexibility and accountability. Intermediate computer skills required.