Aseptic Product Quality Associate Director

Responsibilities:
- Serve as quality subject matter expert for aseptic manufacturing within External & Product Quality Assurance Eye Care Global Team.
- Provide quality leadership for due diligence activities at third-party manufacturers (TPMs/CMOs); perform aseptic assessments.
- Support aseptic-related investigations (root cause identification, risk evaluation, CAPA/Corrrective & Preventive Actions).
- Advance implementation of aseptic best practices across the external manufacturing network; evaluate aseptic standards across internal and external operations.
- Drive continuous improvement by proactively identifying, assessing, prioritizing, and mitigating aseptic risk.
- Provide quality oversight of external manufacturing for regulatory compliance and quality standards.
- Deliver strategic input and recommendations for risk-based decision-making.
- Support escalation, communication, and resolution of significant aseptic quality issues affecting product quality or supply continuity.
- Foster a strong quality culture focused on proactive risk management, continuous improvement, product quality, and operational excellence.

Qualifications:
- Bachelor’s degree in relevant life science or technical field (graduate degree desired); technical/analytical background required.
- 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting; required regulatory inspection experience with direct interaction with regulators.
- Direct plant experience (5+ years preferred).
- Knowledge of biological/pharmaceutical technologies including sterile processes and relevant dosage form technologies.
- Strong urgency management, analytical/problem-solving skills, interpersonal skills, and ability to manage multiple complex tasks.
- Strong QA/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
- Experience working with third-party external manufacturing requirements.