Site Name: USA - North Carolina - Zebulon Posted Date: Jan 9 2025 Are you a Manufacturing Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore. As a Senior Regulatory Compliance Specialist, you will be responsible for ensuring site documentation is compliant with registered details for markets supplied. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Research, prepare & negotiate Quality Agreements (QA and iQA) and Quality Agreement Product Requirements Specifications (QAPRS) for API’s supplied to Zebulon, US marketed products managed by Zebulon, products supplied by Zebulon and Secondary Contract Manufacture (SCM) products managed by Zebulon. Prepare site registration certificates, applications and plant master files for submission to foreign Health Authorities to register the Zebulon site and Secondary Contract Manufacturers (SCMs) for global pharmaceutical supply. Conduct conformance audits for compliance with registered details. Liaise with International Regulatory Affairs and Secondary Contract Manufacturers to provide submission ready CMC documents for products supplied by secondary contract manufacturing sites managed by Zebulon. Conduct impact assessment of approved registered requirements; ensure implementation and compliance. Evaluate and approve Master Batch Documentation for regulatory conformance. Research and prepare product and raw material specifications. Revise documents as required to maintain compliance. Author and produce submission ready CMC documents for FDA Annual Reports. Conduct change control assessments; provide advice and approval. Review regulatory documentation and initiate change control for regulatory mandates. Monitor and evaluate global regulatory policies and practices for impact on products supplied Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s Science Degree in Pharmacy, Science, or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment. Minimum 2+ years compliance related experience. Experience with the application of Quality Systems in manufacturing, warehousing and distribution. Preferred Qualifications: If you have the following characteristics, it would be a plus: Extensive working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC). Good understanding and interpretation of Global regulations pertaining to the manufacture, holding, and distribution of human drug products. Good working knowledge of regulatory affairs, including submissions/supplements/variations and approved dossiers. Demonstrated ability in conformance review of registered documentation and practices. Comprehensive knowledge and application of Quality Management System (QMS). Excellent written and oral communication skills. Excellent organizational skills Good working knowledge of applicable systems including, MERPS, VQD Quality Suites, VQD Reg Vault, Active Dossier CMAC and RADAR About the Zebulon Site GSK’s Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest. Key differentiators about GSK and Zebulon: * Our commitment to inclusion and diversity – we see diversity as a critical advantage of ours * Our focus on cultivating a positive work environment that cares for our employees * Demonstrated opportunities for continued career growth driven by individual ambition * Leaders that care about their teams and growth of both individuals and the company * A priority focus on Safety and Quality * Clean and GMP compliant work environment * Onsite cafeteria * Onsite gym * Temperature-controlled climate * Licensed, onsite Health & Wellness clinic #LI-GSK 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). 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. 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. 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