Corporate QA Compliance Senior Supervisor

Tabuk Pharmaceuticals Manufacturing Company; Dammam; On-site; SAR 60,000 - 100,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Corporate QA Compliance Senior Supervisor, der für die Überwachung und Verbesserung des Qualitätssystems verantwortlich ist. In dieser Rolle werden Sie als Fachexperte für Sterilitätssicherung agieren, Compliance-Überprüfungen durchführen und sicherstellen, dass alle Prozesse den regulatorischen Anforderungen entsprechen. Sie werden auch an der Implementierung von Best Practices zur kontinuierlichen Verbesserung der Abläufe arbeiten. Diese Position bietet die Möglichkeit, einen bedeutenden Einfluss auf die Qualitätssicherung in der pharmazeutischen Produktion zu haben und ist ideal für jemanden mit einer Leidenschaft für Qualität und Compliance.

Qualifications

• 9+ Jahre Erfahrung in der Sterilitätssicherung in einem EU/FDA-zugelassenen Werk.
• Starke Kenntnisse in Qualitätssystemen und eQMS-Tools.

Responsibilities

• Überwachung der Sterilitätssicherungspraktiken und Compliance-Überprüfungen.
• Leitung von Untersuchungen und Ursachenanalysen bei Sterilitätsfehlern.

Skills

Aseptische Verarbeitung

Qualitätssysteme

Analytische Fähigkeiten

Risikomanagement

Problem-Lösungsfähigkeiten

Auditing-Fähigkeiten

Education

Bachelor in Pharmazie

Master in relevanten Bereichen

Tools

TrackWise

Veeva

Job description

We are looking to hire a Corporate QA Compliance Senior Supervisor. This role will be responsible for monitoring and continuously improving the quality system and sterility assurance activities to ensure compliance with regulatory requirements across all sites. The position will also assess the performance of the Quality Management System (QMS) and its alignment with regulatory standards.

Main Responsibilities:

• Implement the day-to-day operations to ensure compliance with the established standards and procedures.
• Identify opportunities for continuous improvement of systems, processes and practices considering ‘international best practice’, improvement of business processes, cost reduction, and productivity improvement.
• Prepare timely and accurate reports of to meet company and department requirements, policies, and standards.
• Auditing / Complaint / Risk Management & Recall Performance update sharing.

Sterility Assurance & Compliance Oversight

• Act as the corporate subject matter expert (SME) for sterility assurance and aseptic operations.
• Perform sterility assurance health checks and compliance reviews across manufacturing sites.
• Lead corporate assessments of Contamination Control Strategies (CCS), EM programs, and aseptic techniques.
• Support manufacturing sites in deploying Annex 1-compliant aseptic behavior and environmental controls.
• Analyze EM trends, sterility test outcomes, and batch release data to identify compliance risks.

Quality Management System (QMS) & Digital Platforms

• Ensure robust QMS integration with sterility assurance requirements across sites.
• Provide oversight and guidance on sterility-related modules within electronic QMS (eQMS) platforms (TrackWise, Veeva, etc.).
• Drive data integrity compliance and system-based documentation review for aseptic processes.

Investigations, Root Cause Analysis & CAPA Effectiveness

• Lead or critically assess major investigations related to sterility failures, environmental deviations, and cleanroom events.
• Apply structured RCA methodologies (e.g., 5 Whys, Fishbone, Fault Tree) to ensure scientific and compliance-based investigation outcomes.
• Review and approve CAPAs with focus on effectiveness, timeliness, and recurrence prevention.

Change Control & Continuous Improvement

• Assess and monitor change controls that impact aseptic processes, CCS, or cleanroom infrastructure.
• Serve as a gatekeeper for corporate review of sterility-impacting changes and qualification protocols.
• Identify systemic gaps and champion improvement initiatives in sterility assurance practices.

Audit Readiness & Inspection Support

• Support internal audit execution and closure of findings related to sterile operations.
• Participate in pre-inspection readiness activities and provide front/back room support during regulatory inspections (FDA, SFDA, EU QPs, etc.).
• Coordinate with site teams to address observations and drive timely, sustainable remediation.
• Implement approved departmental policies, processes, procedures so that work is carried out in a controlled manner.
• Monitor adherence to relevant policies and procedures so that work is carried out in a controlled manner.
• Comply with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment.

Qualifications & Education:

• Bachelor’s degree in Pharmacy, Microbiology, or Life Sciences (Master’s or relevant certifications are a plus).
• 9+ years of specialized experience in sterility assurance within an EU and/or FDA-approved sterile manufacturing site.
• Proven expertise in aseptic processing, EM programs, CCS implementation, and cleanroom behavior.
• Strong working knowledge of quality systems, eQMS tools (e.g., Veeva, TrackWise), and regulatory inspection frameworks.
• Proficient in managing investigations, change control, and complex root cause analysis.
• Strong analytical and problem-solving skills.
• Strong auditing skills and experience.
• High sense of ownership, critical thinking, and cross-functional leadership.

Preferred Certifications

• Certified Pharmaceutical GMP Professional (CPGP) – ASQ.
• Certified Quality Auditor (CQA) – ASQ.
• Lean Six Sigma Green Belt / Black Belt – for problem-solving and continuous improvement
• Annex 1 / Aseptic GMP training certification from recognized regulatory bodies or training institutions.