Associate Director - Sterile Manufacturing

Job Description Summary

Lead sterile manufacturing operations, ensure compliance with USFDA and other regulatory requirements, and oversee validation activities in the sterile plant to maintain the highest standards of quality and efficiency.

Job Description

• Oversee end-to-end manufacturing activities in the sterile plant, ensuring compliance with cGMP and regulatory requirements.
• Ensure the facility is always audit-ready by maintaining compliance with USFDA, MHRA, and other global regulatory standards.
• Plan, execute, and review validation protocols for sterile manufacturing processes, equipment, and systems.
• Work closely with the QA team to implement corrective and preventive actions (CAPAs) and ensure documentation accuracy for audits.
• Develop and implement training programs for the sterile manufacturing team to uphold compliance and operational excellence.
• Lead root cause analysis, manage deviations, and implement CAPAs for manufacturing and validation-related issues.
• Identify and drive continuous improvement initiatives to enhance manufacturing efficiency and reduce operational costs.
• Act as a liaison with regulatory bodies, external auditors, and internal stakeholders, providing updates on compliance and validation activities.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.