Associate Director, Quality Control - Remote

Overview

The Associate Director, Quality Control is responsible for overseeing and managing the quality control operations to ensure compliance with GMP and regulatory standards. This role involves driving continuous improvement initiatives, and will develop, execute, and periodically evaluate QC practice and processes to ensure that QC operations are efficient, timely, and safeguard data integrity.

In Short

• Lead and mentor the QC team to foster a culture of quality and accountability.
• Review and approve QC data, deviations, and corrective actions.
• Implement process improvement initiatives for operational efficiency.
• Oversee release and stability testing of drug products.
• Manage the stability program for timely testing and data review.
• Communicate quality issues to management promptly.
• Author and approve QC related documents.
• Participate in testing lab audits and regulatory submissions.
• Support budget planning for QC operations.
• Ensure compliance with GMP and regulatory requirements.

Requirements

• Bachelor’s degree or higher in chemistry, biochemistry or related field.
• 8+ years of experience in a GMP QC environment.
• Experience with QC devices is desirable.
• Proficiency in cGMP and FDA/EMA regulations.
• Strong knowledge of QC microbiological requirements.
• Excellent leadership and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to adapt to changing business needs.

Benefits

• Comprehensive benefits package including 401(k) with company match.
• Inclusive family building benefits.
• Flexible time off and summer/winter shutdowns.
• Paid family leave and disability insurance.
• Life insurance coverage.