Site Name: Cambridge Binney Street Posted Date: Feb 3 2025 Job posting deadline is February 14, 2025 Job Title: Compliance Specialist Location: Cambridge Binney Street Job Purpose: To ensure that the site complies with cGMP, the GSK Quality Management System and all regulatory, licensing and pharmacopeia requirements. Manage the site’s Management Monitoring (Level 1) audit program, performing CAPA verification steps to ensure “in place” and “in use” and effectiveness. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Key Responsibilities Manage the site Management Monitoring (Level 1) audit program ensuring delivery of cGMP compliance and QMS “in place” and “in use” expectations to deliver inspection readiness. Support the Quality Alert / Quality bulletin processes. Support the site Pest Control programme and all Level 3 and 4 inspections through execution of Management Monitoring. Carry out verification of audit CAPA as required to ensure these are in place, in use and effective. Manage the QMS implementation process as applicable to Engineering operations ensuring that all QMS document updates are assessed for applicability and implemented to schedule. Act as QMS Champion across Engineering operations providing support, training and coaching for site personnel as well as partnering with Quality Organization as required. Provide QMS updates at Site Quality Council meetings. Act as liaison between Engineering and training team to ensure that department training packages are maintained to the expected standards and are current. Drive and improve the compliance culture to ensure Engineering department audit readiness Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in science or engineering 3+ years of experience in cGMP Compliance 3+ years of experience auditing Quality Management Systems at Level 1 Proficient in Microsoft Office programs(Excel, Power Point, Word) Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in major regulatory audits (Level 3 / 4). Experience of pharmaceutical quality management systems. Knowledge of external regulators’ expectations #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. 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