Associate Director, Quality Assurance – Combination Products - Remote

Overview

The Associate Director, Quality Assurance will oversee the quality assurance for combination product projects from inception to commercialization, ensuring compliance with regulatory standards.

In Short

• Oversee quality and compliance of combination products.
• Develop and implement quality strategies and processes.
• Act as the QA contact for quality-related inquiries.
• Collaborate with cross-functional teams to ensure compliance.
• Define and implement quality standards and metrics.
• Stay updated with medical device regulations.
• Participate in product documentation development.
• Identify improvement opportunities within quality systems.
• Communicate updates on quality status to management.
• Participate in regulatory audits and ensure compliance.
• Availability for 5-15% travel.

Requirements

• Bachelor’s degree in a related field; advanced degree preferred.
• 8+ years of experience in quality oversight of drug products.
• Experience with design controls and combination products.
• Knowledge of global medical device standards.
• Familiarity with product lifecycle management.
• Experience with biological drug products is a plus.
• Excellent communication and interpersonal skills.
• Ability to resolve complex problems effectively.
• Alignment with company core values.

Benefits

• Competitive salary range.
• Opportunity to work in a leading biotechnology company.
• Collaborative work environment.
• Opportunity for professional growth.
• Work on innovative products that impact patient care.