Associate Director, Product Quality

📋 Description

• Design, implement, and continuously improve a scalable Quality Management System aligned with the
• Provide GxP quality oversight across internal functions and external partners, including Contract
• Lead core quality processes, including deviation management, Corrective and Preventive Actions
• Oversee quality activities supporting regulatory submissions, including Investigational New Drug
• Partner with technical operations and development teams on Chemistry, Manufacturing, and Controls
• Oversee batch record reviews, product release decisions, and quality assessments of analytical and

🎯 Requirements

• Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or a related scientific
• At least 8 years of experience in pharmaceutical quality roles, including 3 or more years in a
• Strong knowledge of GxP regulations and guidelines, including applicable FDA, EMA, and ICH
• Hands-on experience with document control and quality management systems, such as ZenQMS, Veeva
• Familiarity with multiple pharmaceutical dosage forms and manufacturing models involving external
• Demonstrated ability to establish and improve quality systems while balancing regulatory

🎁 Benefits

• Competitive annual base salary: $117,000–$189,200, depending on qualifications, experience, skills
• Performance-based bonus: Eligible full-time employees may receive a company bonus based partly on
• Retirement benefits: Eligibility to participate in a company-sponsored 401(k) plan and pension
• Healthcare coverage: Eligible employees can access medical, dental, vision, and prescription drug
• Paid time off: Vacation benefits and certain leave programs.
• Flexible benefits: Options may include healthcare and dependent care benefits, subject to