Process Lead

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.

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.