Manager - Sterility Assurance

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Job Summary / Main Purpose

The Sterility Assurance Quality Manager is a senior role responsible for overseeing the sterility assurance programs at Julphar’s sterile manufacturing facilities. This role provides leadership, governance, and technical expertise to ensure microbial control across cleanroom operations, utilities, environmental monitoring, aseptic practices, and sterile product testing. The role is pivotal in developing and implementing robust contamination control strategies aligned with current regulatory expectations (FDA, EMA, WHO, etc.), and ensuring the site maintains a state of compliance.

The position requires strong collaboration with cross-functional stakeholders, including Quality Control Microbiology, Manufacturing, Engineering, Validation, and Regulatory Affairs. The incumbent will serve as the Subject Matter Expert (SME) for sterility assurance and microbial control during audits and inspections.

Key Responsibilities

• Lead the implementation and governance of sterility assurance and microbial control strategies across all sterile manufacturing operations.
• Develop and maintain a robust Contamination Control Strategy (CCS) in line with Annex 1, WHO, FDA, and company expectations.
• Provide QA oversight for environmental and personnel monitoring, aseptic practices, cleanroom classification, and utilities testing (e.g., WFI, compressed air).
• Review and approve risk/gap assessments related to sterility assurance and microbial control.
• Ensure appropriate qualification and validation activities related to aseptic processes, including media fills, equipment qualification, and cleanroom design.
• Oversee gowning qualification programs and ensure personnel participation in media fills is compliant and appropriately documented.
• Provide technical guidance for bioburden, endotoxin, and sterility testing, including review of results and lab investigations.
• Serve as QA SME during regulatory inspections, external/internal audits, and provide timely support in audit readiness and observation closures.
• Lead or support root cause investigations for microbial excursions, including OOLs, sterility failures, EM deviations, etc., and oversee the implementation of CAPAs.
• Collaborate with QA Operations, QC Microbiology, Validation, and Engineering to ensure holistic microbial control across the facility.
• Evaluate and promote the use of rapid microbiological methods (RMM) and emerging technologies for microbial monitoring.
• Oversee assessment and control of critical consumables used in aseptic areas.
• Contribute to capital projects involving sterile manufacturing by providing sterility assurance input during facility or process design reviews.
• Participate in and contribute to audit readiness programs, including development of internal self-inspection systems.
• Ensure sterility assurance practices comply with global regulatory requirements and internal standards, with full alignment to Data Integrity and GMP principles.
  
  

• Technical Expertise Deep understanding of sterility assurance principles, cleanroom operations, contamination control, environmental monitoring, and aseptic processing.
• Regulatory Knowledge Strong knowledge of GxP, FDA, EMA, and WHO guidelines, particularly Annex 1 revisions, with direct experience handling regulatory inspections and responses.
• Leadership & Collaboration Effective leadership in cross-functional environments with ability to manage diverse stakeholders and influence decision-making.
• Problem Solving & Decision-Making Skilled in root cause analysis, microbiological investigations, and risk-based decision-making in sterile operations.
• Project & Change Management Demonstrated ability to lead quality improvement initiatives and drive change within a regulated environment.
• Communication & Stakeholder Engagement Excellent communication, interpersonal, and stakeholder management skills, with fluency in English (written and verbal).
• Training & Development Proficient in training staff on aseptic techniques, microbiology testing, and GMP compliance for sterile operations.
  
  

• Education: Master’s degree in Microbiology, Biotechnology, or Life Sciences (PhD is a plus).
• Experience:
• Minimum 15 years of experience in pharmaceutical manufacturing, with at least 5–7 years in a leadership role focused on Sterility Assurance.
• Proven experience in aseptic manufacturing, microbiological monitoring, and contamination control.
• Direct involvement in managing regulatory inspections, including FDA, EMA, and local health authorities.
• Experience in QC Microbiology and cross-functional collaboration with QA, QC, Production, and Validation teams.
• Strong background in validation and qualification of sterile areas, cleanrooms, and aseptic processes.
• Familiarity with global regulatory frameworks and trends related to sterility assurance, contamination control, and Annex 1 compliance.
• Demonstrated capability in managing project teams and leading compliance-driven initiatives in a regulated setting.
  

• Certification in Quality Management Systems (e.g., ASQ CQA)
• Training in Data Integrity, Annex 1, and Aseptic Processing
• Experience with rapid microbiology methods (RMM) and advanced EM tools
• Strong knowledge of quality risk management (ICH Q9) and root cause analysis methodologies (e.g., Fishbone, 5 Whys)
• Proficient in EQMS systems and laboratory information management systems (LIMS)