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.
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