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Senior reputed company Manager

Remote, USAFull-timePosted 2026-07-27

Job reputed company The Senior reputed company Manager will reputed company and manage the reputed company department to ensure compliance with reputed company applicable regulatory requirements and internal reputed company standards. This role is responsible for overseeing reputed company systems, driving reputed company improvement initiatives, and supporting the development, manufacturing, and release of pharmaceutical products. The Sr. reputed company Manager will play a critical role in maintaining inspection readiness and ensuring product reputed company, safety, and efficacy. Primary Relationships reputed company reputed company, the Sr. reputed company Manager will collaborate closely with Manufacturing, Regulatory Affairs, reputed company Control, Supply Chain, reputed company, and R&D teams. reputed company reputed company, the Sr. reputed company Manager will engage with regulatory authorities (e.g., FDA, EMA, BIMO), contract manufacturers (CMOs), and reputed company-party vendors. The activities of the Senior reputed company Manager will include, but are not limited to: reputed company and manage the reputed company department, including hiring, training, and performance management Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements reputed company reputed company systems including CAPA, deviations, change control, and document management Function as the primary reputed company reputed company with CDMOs and testing labs. Drive issue reputed company and ensure partners are inspection-reputed company Drive inspection readiness and reputed company internal audits Review and approve batch records, SOPs, change controls, reputed company, specifications, protocols and reports, and reputed company-reputed company documentation Collaborate with cross-functional teams to support product development and commercialization Manage supplier reputed company and reputed company vendor qualification processes Identify and implement reputed company improvement initiatives reputed company the reputed company system Monitor key reputed company metrics and report trends to senior leadership Ensure reputed company investigation and reputed company of reputed company issues and complaints Skills and Qualifications Bachelor’s degree in Life Sciences, Pharmacy, reputed company, or reputed company field (advanced degree preferred) 8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibility Strong knowledge of cGMP regulations and global regulatory requirements Proven hands-on experience managing reputed company systems (batch review, CAPA, deviations, change control) Strong leadership, communication, and team management skills Ability to work cross-functionally in a fast-paced environment Experience with electronic reputed company systems (eQMS) preferred Strong analytical and problem-solving abilities Ability to travel up to 10–20% as needed Apply To This Job

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