Sr. Quality Assurance Manager (Pharma)
$150,000–$175,000 year
HybridTarrytown, New York, United States
Job Summary
Lead quality oversight for assigned brands and contract manufacturing partners, managing the full product lifecycle from new introductions through post-market support. Establish and maintain comprehensive policies, SOPs, and design controls compliant with FDA, ISO, and EU MDR guidelines while driving continuous improvement across partner quality systems. Conduct cGMP audits, evaluate partner systems, negotiate quality agreements, and lead resolution of deviations, nonconformances, and CAPAs. Provide strategic quality leadership to cross-functional teams including Regulatory Affairs and New Product Development, ensuring adherence to risk management principles and regulatory standards. Hybrid work schedule with Tarrytown office presence Tues/Wed/Thurs; 20% travel required.
Required Qualifications
- Minimum of a Bachelor's degree in scientific discipline
- 8+ years of Quality Assurance experience within medical devices and/or pharmaceutical manufacturing environments
- Knowledge of FDA 21 CFR Parts 211 and 820, FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical device and pharmaceutical quality requirements
- 20% ability to travel via car, plane, rail
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to write reports, business correspondence, and procedure manuals
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
- Ability to apply concepts of basic algebra and geometry
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
- Ability to deal with problems involving several concrete variables in standardized situations
- Regularly required to sit
- Frequently required to talk or hear
- Occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl
- Occasionally required to lift and/or move up to 10 pounds
- Close vision
- Ability to adjust focus
- Applicants must be authorized to work for ANY employer in the U.S.
- All applicants must be able to work in our Tarrytown office Tues/Wed/Thurs (remote on Mon/Fri)
Desired Qualifications
- Experience supporting medical device quality systems, design controls, and risk management activities is preferred
- Experience with leading and managing cGMP audits
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