About the position
The Quality Assurance Regulatory and Compliance Manager is responsible for compliance oversight of quality systems and quality risks at the Marietta facility to ensure compliance with GSK procedures, policies, and standards and the regulations of all markets for which Marietta manufactures product. This role is crucial in maintaining the inspection readiness status of the site and overseeing both internal audit and external inspection programs. The manager will lead the QA Regulatory/Compliance team, ensuring that all team members exhibit a quality mindset in their performance and behaviors. This includes identifying the strengths of each team member and ensuring that they are well-suited for their roles. The manager is accountable for the development of the QA Compliance team and for the deployment of a system for Regulatory Inspection Management Preparation (RIMP) for the Marietta site. In this position, the manager will plan and lead RIMP activities, including the escalation of RIMP progress and issues to the site Quality Council. They will develop and implement inspection management strategies and are responsible for planning, scheduling, hosting, and leading the execution of all external regulatory and internal global quality audits of the Marietta facility. The manager will also manage audit responses and Corrective and Preventive Actions (CAPAs), ensuring that the site-level internal audit program is effective and that routine assessments of inspection readiness status are performed. Additionally, the manager will oversee data integrity management for the Marietta site, owning the data integrity program and related local procedures. They will be accountable for managing cGMP risks using the site risk management process and integrating risk management with inspection readiness activities. The manager will also oversee the Supplier Quality Assurance program to ensure the use of approved suppliers and service providers. As a compliance expert for Marietta, the manager will serve as the single point of contact for global QA and QC functions, responsible for regulatory intelligence and updates. They will measure and communicate QA Compliance performance and oversee site conformance, including the assessment of change controls for regulatory impact and the review and approval of regulatory submissions and dossiers. All responsibilities must be performed in compliance with GSK safety procedures and applicable EHS regulations, standard operating procedures, and industry practices.
Responsibilities
- Lead the QA Regulatory/Compliance team and ensure that all team members display a quality mindset in their performance and behaviors.
- Identify the strengths of each team member and ensure that each team member is a good fit for their role.
- Accountable for development of the QA Compliance team.
- Accountable for inspection readiness and deployment of a system for Regulatory Inspection Management Preparation (RIMP) for the Marietta site.
- Plan and lead RIMP activities including escalation of RIMP progress and issues to site Quality Council.
- Develop and implement inspection management strategies.
- Accountable for planning, scheduling, hosting and leading the execution of all external regulatory and internal global quality audits of the Marietta facility.
- Manage audit responses and CAPA's.
- Accountable for the site-level internal audit program; perform routine assessments of inspection readiness status of the site, internal audits and supplier audits as a lead auditor.
- Responsible for the ongoing development of the internal auditor team.
- Ensure value added inspections are being performed and are effective.
- Responsible for data integrity management for the Marietta site.
- Owner of data integrity program and related local procedures.
- Accountable for the management of cGMP risks using the site risk management process.
- Integrate risk management and inspection readiness activities.
- Accountable for the Supplier Quality Assurance program for the Marietta site to ensure the use of approved suppliers and approved service providers.
- Compliance expert for Marietta (cGMPs, pharmacopoeia, regulations and guidelines) - Single point of contact for global QA and QC functions responsible for regulatory intelligence and regulation and guidance updates.
- Measure and communicate on QA Compliance performance.
- Site regulatory expert.
- Oversees site conformance, including assessment of change controls for regulatory impact, site level review and approval of regulatory submissions and dossiers, maintaining core files and site master file.
Requirements
- B.S or B.A in a relevant scientific, quality system or technical discipline.
- 5 years prior experience in Quality Assurance or Quality Control (Quality Systems, compliance, product release, auditing) within clinical or commercial organization with licensed biopharmaceutical or biological products.
Nice-to-haves
- Certification such as ASQ Certified Quality Auditor preferred.
- GSK Auditor certification or development as certified GSK auditor preferred.
- Previous leadership experience preferred.
Benefits
- Comprehensive benefits program including health insurance, retirement plans, and paid time off.
