Team Leader - Sterile Value stream (QA)

Julphar; United Arab Emirates; On-site; AED 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in the United Arab Emirates is seeking a professional with over 10 years of experience in quality assurance and sterility to oversee and implement compliance strategies in sterile manufacturing. The ideal candidate will have a robust understanding of GxP guidelines and be proactive in engaging with stakeholders to drive quality improvements. This role offers the opportunity to impact patient care positively.

Qualifications

• Minimum 10 years of experience in the pharmaceutical industry.
• Extensive experience leading teams.
• Proficient in GxP, FDA, EU guidelines.
• Experience with microbial monitoring in sterile environments.

Responsibilities

• Provide oversight for sterility assurance in manufacturing.
• Handle deviations and quality improvement projects.
• Govern microbial monitoring and testing strategies.
• Collaborate with QA teams for audit readiness.

Skills

Proactive engagement

Regulatory compliance knowledge

Strong communication skills

Team collaboration

Experience with OOS results

Education

Degree in Pharmacy / Life Sciences

Job description

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 talent, create a healthy work environment, and accomplish our goals through world‑class research and the compassion and commitment of our employees.

Job Summary / Main Purpose

• Provide quality assurance oversight for sterility assurance monitoring, control standards, and knowledge management in monitoring control.
• Lead the sterility assurance quality team and support the value stream in matters related to sterility assurance.
• Develop contamination control strategy for manufacturing facilities in Julphar.
• Provide quality assurance governance for the microbial monitoring controls.

Key Responsibilities

• Implement sterility assurance program on site for the sterile manufacturing facilities.
• Handle deviations, change control, market complaints, CAPA and risk assessment related to sterile operations.
• Review and approve gap/risk assessments relating to sterility assurance.
• Provide QA oversight to sterility assurance for site manufacturing processes and products, including setting product specifications and in‑process controls.
• Ensure gowning qualifications for persons working inside aseptic areas and their media fill participation.
• Provide input on sterility assurance for qualification and validation strategies including media fills and production equipment qualifications.
• Collaborate with operations QA oversight team to provide a holistic microbial contamination control strategy, risk assessment and mitigation plans at each sterile manufacturing plant.
• Demonstrate strong technical knowledge in design of cleanroom facilities, material flow, personnel flow, area classification and cGMP compliance.
• Govern all microbial monitoring controls and provide governance of microbial testing strategies for utilities, environmental and personnel monitoring.
• Provide expertise during root cause analysis investigations, including OOL investigations, bioburden, endotoxin and sterility test failures, and support as SME during external regulatory inspections.
• Act as the quality partner to the teams within sterility assurance and work closely with the QA oversight and operations team, partnering also to the corresponding value stream QA team.
• Ensure that all in‑process testing (bioburden, endotoxin) and final product testing (sterility testing) complies with pharmacopeial expectations.
• Provide inputs in quality decisions for capital projects, consulting with other stakeholders and QA operations leaders.
• Review and evaluate the use of rapid microbiology methods and new technology to improve microbial monitoring controls.
• Contribute to audit readiness team and internal audit, external regulatory audits and compliance responses.
• Assess and control critical consumables used in aseptic areas.

Core Competency

• Proactive and timely engagement of internal or external stakeholders as necessary.
• Engage stakeholders to formulate and drive projects related to quality improvement.
• Apply good communication and project management skills.
• Highly result‑oriented with strong sense of accountability & ownership.
• In‑depth knowledge of industry standards, regulations guidelines and excellent record keeping; experience in handling regulatory audit questions and setting action plans.
• Expert in handling OOS results in microbiological analysis, water and environmental monitoring.
• Strong personnel handling skills, effective team communication and motivational skills.
• Capable of suggesting ideas in a structured manner and having good command of English language.
• Team player with a proactive and collaborative approach, managing stakeholders enthusiastically.

Qualifications, Key Experiences / Functional Knowledge Requirements

• Degree in Pharmacy / Life Sciences.
• +10 years of experience as a professional in the pharmaceutical industry or equivalent combination of education and experience.
• Extensive professional experience leading (project) teams.
• Demonstrated experience in regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
• Experience in the manufacturing of sterile products.
• Experience in microbial monitoring of aseptic manufacturing areas.
• Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology / Sterility Assurance context.
• Experience in interacting with regulatory authorities including submissions and inspections.
• Experience in working in a global environment.
• Sterile plant working experience is desirable (vial, ampouls, PFS, Lyo and cartridge filling).

We value people from different backgrounds. Could this be your story? Apply today or visit Julphar to read more about us and the journey of Julphar.