Associate Director, Product Quality - Remote

Overview

The Associate Director of Product Quality is responsible for ensuring the quality of assigned products, including pharmaceuticals, biologics, and medical devices, while meeting business objectives and compliance with regulations.

In Short

• Lead a team of Quality professionals for product transfer activities.
• Develop and implement Global Product Quality Assurance strategy.
• Serve as the primary Quality contact between third party manufacturers and AbbVie Operations.
• Make key decisions on product quality and compliance issues.
• Manage relationships with Third Party Manufacturers and internal stakeholders.
• Lead audit plans and inspection readiness activities.
• Support regulatory filings and marketing authorization dossiers.
• Develop and maintain quality systems across AbbVie operations.
• Influence decision making to ensure quality requirements are met.
• Engage with regulatory authorities for inspections and approvals.

Requirements

• Bachelor’s Degree in Life Science or related field; Graduate degree desired.
• 10+ years of experience in Quality Assurance Operations Management.
• Knowledge of pharmaceutical technologies and regulatory requirements.
• Strong analytical and problem-solving skills.
• Experience in managing third-party external manufacturing requirements.
• Ability to manage multiple complex tasks simultaneously.
• Excellent interpersonal and communication skills.
• Direct plant experience in a pharmaceutical setting preferred.
• Experience in quality assurance/control and regulatory environments.
• Familiarity with global compliance and quality metrics.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation, holidays, and sick leave.
• Participation in short-term and long-term incentive programs.
• Opportunities for professional development and growth.
• Supportive work environment focused on innovation and diversity.