Job Description One of our large pharmaceutical clients is looking to hire a Compliance Specialist to join their Quality Assurance team in Malvern, PA. This position requires an individual to be on-site in Malvern. The individual will be preparing for and supporting external GMP audits and inspections for the Health Authority, Customer, ERC, etc. Additionally, they will be providing compliance subject matter expertise to the manufacturing sites and site-based projects. Main responsibilities will include: Quality Compliance: -Support internal and external audit preparation and execution for the Malvern JSC site. -Accurate Quality Review of Quality Agreements ensuring compliance to local and global procedures. Coordinate review by stakeholders. -Coordinate Gap Assessment process at the site. Coordinate SME gap assessments, track updates required at a local level. Complete required documentation based on the assessments following global procedures. -Schedule, run, and participate in mock recall activities including the facilitation of any meetings and follow-up as the process completes. -Assist in compiling of information for the Site Quality Risk Register. Update presentations and assist with gathering information. -Assist in writing and editing procedures and quality investigations -Assist in compiling the Site Master File, coordinate SME updates and reviews, final document compilation Training Assistance may include: -Facilitate the asynchronous Train the Trainer module by grading submittals and providing guidance/feedback to trainees. -Edit training modules -Create courses in SUMMIT We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements -Bachelor Degree in Science or related field -At least 5 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience. -Experience with risk assessment processes. -Knowledge of global GMP regulations is required. -Strong analytical skills. Ability to clearly articulate issues. -Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community. -Delivers on commitment timelines and has high sense of urgency. -QA or RA certification is preferred. -Large molecule experience -Experience supporting internal or external audits is preferred. -Experience working with the Health Authority for inspections null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.