Senior Quality Manager

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