Associate Director, Aseptic Product Quality

• Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies that ensure robust product quality assurance.
• Conduct due diligence visits to prospective external partners (TPMs/CMOs) as a member of cross-functional teams.
• Perform hands-on assessments of aseptic manufacturing operations, processes, and controls, while driving the implementation and adoption of aseptic best practices across external partners to strengthen quality systems and operational performance.
• Provide technical quality leadership for aseptic-related investigations, including root cause identification, risk evaluation, and the development of corrective and preventive actions.
• Monitor and evaluate emerging technologies, regulatory expectations, and industry trends related to aseptic manufacturing and contamination control.
• Provide quality oversight of external manufacturing operations to ensure compliance with applicable regulatory requirements and quality standards, while proactively identifying, assessing, prioritizing, and mitigating aseptic risks.
• Deliver strategic input and recommendations to support risk-based decision-making for aseptic manufacturing and external quality operations.
• Build and sustain collaborative relationships with AbbVie internal manufacturing sites, global aseptic teams, and cross-functional stakeholders.
• Support the escalation, communication, and resolution of significant aseptic quality issues that may affect product quality or supply continuity.
• Foster and promote a strong quality culture centered on proactive risk management, continuous improvement, product quality, and operational excellence.

Qualifications

• Bachelor's degree in a relevant Life Science or other technical discipline required. Technical or analytical background required for problem resolution with technical, quality, product and/or engineering-related issues.
• Total combined years of experience: minimum of 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended-release products, coating solutions, and/or active pharmaceutical ingredients).
• Possesses the knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, the ability to manage multiple complex tasks simultaneously, and is capable of performing as a leader, team member and individual.
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• A wide range of activities is undertaken, from long-term strategy development to short-term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy corporate, divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
• Experience working with the requirements for third-party external manufacturing.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html