Senior Manager, Quality Assurance

📋 Description

• Lead quality assurance oversight of transport validation and primary and secondary packaging
• Represent Quality Assurance on cross-functional teams, providing guidance on quality, compliance
• Serve as a subject matter expert for deviations, corrective and preventive actions (CAPAs), change
• Review and approve CMO documentation, including product specifications, master batch records
• Oversee quality aspects of validation, packaging, and testing activities conducted at external
• Establish, monitor, and report quality performance metrics, emerging risks, and compliance

🎯 Requirements

• Bachelor's degree in a scientific or technical discipline.
• At least 8 years of experience in the pharmaceutical industry, with substantial experience in
• Demonstrated experience overseeing transport validation and packaging process validation, strongly
• Proven experience managing quality activities related to validation, packaging, and testing at
• Familiarity with process performance qualification (PPQ), commercial manufacturing readiness, and
• Strong knowledge of U.S. and global Good Manufacturing Practice (GMP) regulations, quality

🎁 Benefits

• Work flexibility: Remote work opportunity within the United States.
• Professional impact: The opportunity to support pharmaceutical commercial readiness and help
• Leadership opportunities: Collaboration with cross-functional teams and senior management on
• Technical development: Exposure to pharmaceutical validation, packaging operations, global GMP
• Compensation and additional benefits: Salary, healthcare coverage, retirement plans, paid time off