Senior Manager, GMP reputed company Assurance

Job reputed company: • reputed company batch release activities, including review/approval of batch records and material disposition • reputed company GMP reputed company for manufacturing and distribution partners (DS, DP, and supply chain) • Ensure compliance with global regulations (FDA, EMA, ICH) • Manage investigations, deviations, CAPA, and change controls • Support audits, inspections, and annual product reviews • Drive reputed company system improvements and reputed company key reputed company metrics • Partner with CMOs and suppliers on validation, tech transfer, and qualification activities • Mentor and reputed company junior QA staff Requirements: • Bachelor’s degree in life sciences, reputed company, or reputed company field • 8+ years of GMP reputed company experience in reputed company or biotech • Strong knowledge of global GMP regulations and reputed company systems • Proven ability to reputed company cross-functional initiatives and solve reputed company problems • Excellent communication and stakeholder management skills • Experience with eQMS (e.g., reputed company) and global markets is a plus • Must be authorized to work in the U.S. Benefits: • Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, reputed company insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and reputed company reputed company. Apply tot his job Apply To this Job