Team Lead -Deviation & CAPA

Julphar; Ras Al Khaimah; On-site; AED 279,000 - 390,600; Full time

Job summary

A leading pharmaceutical company in Ras Al Khaimah is seeking a Risk & Quality Management Lead to oversee a robust risk management framework in alignment with regulatory standards. Your role will involve facilitating risk assessments, training teams, and ensuring compliance with GMP and FDA regulations. Candidates should possess a Bachelor's in Pharmacy, 7 years of relevant experience, and strong analytical skills, making a positive impact in our mission for quality healthcare solutions.

Qualifications

• Minimum 7 years of experience in pharmaceutical quality management, focusing on Risk Management and QMS.
• Professional certifications in Risk Management or Quality Management are highly desirable.
• Comprehensive knowledge of GMP, FDA regulations, and global regulatory standards.

Responsibilities

• Establish and improve the risk management framework compliant with ICH Q9 and GMP.
• Lead formal risk assessments for manufacturing, engineering, and quality systems.
• Monitor key risk indicators to assess the risk management program's performance.

Skills

Risk management methodologies

GMP understanding

Leadership skills

Analytical abilities

Quality improvement tools

Education

Bachelor's degree in Pharmacy

Master's degree or higher qualification

Tools

Microsoft Office

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

Job Description

The Risk & Quality Management Lead is responsible for establishing, implementing, and continuously improving a robust risk management framework in alignment with ICH Q9, GMP requirements, and internal company policies. This role is critical to ensuring that risk‑based thinking is embedded across all aspects of the Quality Management System (QMS) and that quality operations support regulatory compliance, operational excellence, and strategic business objectives.

Key Responsibilities

• Risk Management Leadership
  • Develop, implement, and maintain an effective risk management framework compliant with ICH Q9, GMP, and corporate policies.
  • Lead and facilitate formal risk assessments (e.g., FMEA, Fault Tree Analysis) for manufacturing, engineering, and quality systems.
  • Promote risk‑based thinking across core QMS processes including CAPA, change control, audits, deviations, and validation activities.
• Risk Governance and Monitoring
  • Track and manage risk mitigation plans, ensuring timely execution, effectiveness of controls, and documentation of outcomes.
  • Lead periodic risk reviews and maintain updated site‑level risk registers.
  • Define, monitor, and report on key risk indicators (KRIs/KPIs) to assess the maturity and performance of the risk management program.
• Training & Culture Enablement
  • Provide training, coaching, and guidance on risk management tools, methodologies, and best practices across cross‑functional teams.
  • Champion a culture of proactive risk identification, analysis, and control.
• QMS Oversight and Continuous Improvement
  • Oversee the lifecycle and compliance of key QMS components, including audits (internal and external), deviations, documentation, change control, CAPA, and customer complaints.
  • Support Data Integrity and documentation compliance initiatives across all quality‑related systems.
  • Streamline quality processes and documentation for enhanced usability, efficiency, and compliance.
• Strategic and Cross‑Functional Engagement
  • Enable cross‑functional risk‑based decision‑making aligned with regulatory and business priorities.
  • Drive harmonization of local risk management processes with global corporate quality standards.
  • Participate in site‑level strategic planning by integrating risk and quality perspectives into long‑term goals and objectives.
  • Ensure clear communication and alignment across departments regarding QMS performance, risk posture, and key quality challenges.
• Regulatory Compliance
  • Ensure strict compliance with company standards, GMP guidelines, FDA regulations, and international quality requirements.

Core Competencies

• Expertise in risk management methodologies and QMS frameworks.
• Strong technical understanding of GMP, regulatory requirements, and audit processes.
• Effective leadership and team management skills.
• Advanced problem‑solving and analytical abilities.
• Proficient in quality improvement tools and continuous improvement methodologies (e.g., Lean, Six Sigma).
• Strong interpersonal, communication, and presentation skills.
• Business acumen with focus on cost‑efficiency and strategic decision‑making.
• Adaptability and strength in managing organizational change.
• Results‑oriented with a structured, process‑driven mindset.
• Excellent time, task, and team management capabilities.
• A solution‑focused mindset with sound judgment in complex situations.
• Proven ability to foster collaboration across functional areas.

Qualifications & Experience

• Bachelor's degree in Pharmacy is required; a Master's degree or higher qualification is preferred.
• Professional certifications in Risk Management, Quality Management, or related fields (e.g., ASQ Certified Quality Manager) are highly desirable.
• Minimum 7 years of experience in pharmaceutical quality management, with a focus on Risk Management and QMS.
• Comprehensive knowledge of GMP, FDA regulations, and global regulatory standards.
• Proficient in Microsoft Office tools (Word, Excel, PowerPoint).
• Strong analytical, documentation, and communication skills.

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