Quality Assurance Regulatory and Compliance Manager

Reference #: 403820 Site Name: USA - Pennsylvania - Marietta Posted Date: Sep 6 2024 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.The Quality Assurance Regulatory and Compliance Manager is responsible for oversight of the inspection readiness status of the site and for the internal audit and external inspection programs. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: 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. Perform all job responsibilities in compliance with the GSK safety procedures and all applicable EHS regulations, standard operating procedures, and industry practices. Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 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. Preferred Qualifications: If you have the following characteristics, it would be a plus: Certification such as ASQ Certified Quality Auditor preferred. GSK Auditor certification or development as certified GSK auditor preferred. Previous leadership experience preferred #LI-GSK #mariettavaccines #globalsupplychain #GSKmarietta Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Created: 2024-11-02