Team Leader – Sterile Value Stream (QA)

About the role

Julphar is seeking a senior QA professional to lead the Sterile Value Stream. The role provides oversight of sterility assurance, microbial monitoring and contamination control across sterile manufacturing sites, ensuring compliance with global regulatory standards.

Key responsibilities

• Implement and maintain the sterility assurance program for all sterile manufacturing facilities.
• Lead deviation handling, change control, CAPA, market complaints and risk assessments related to sterile operations.
• Provide QA governance for microbial monitoring controls, utilities, environmental and personnel monitoring.
• Review and approve gap and risk assessments, and support root‑cause investigations for OOS, bioburden, endotoxin and sterility test failures.
• Collaborate with operations and QA oversight teams to develop holistic contamination control strategies and qualification/validation plans.

Required profile

• Degree in Pharmacy, Life Sciences or related field with at least 10 years of pharmaceutical QA experience.
• Proven experience leading project teams and managing regulatory compliance (GxP, FDA, EU).
• Hands‑on experience in sterile product manufacturing, microbial monitoring and cleanroom design.
• Strong track record of interacting with regulatory authorities and supporting inspections.

Required skills

• Microbiological analysis, water and environmental monitoring.
• Sterility testing, bioburden and endotoxin assessment.
• Media fill execution and aseptic gowning qualification.
• Rapid microbiology methods and risk assessment techniques.
• CAPA management and root‑cause analysis.