Compliance Operation Manager - GCC

About Sobi

At Sobi, we believe that every individual brings unique strengths to our team, and together, we make a meaningful difference in the lives of people living with rare diseases. Our mission is to develop and deliver innovative therapies that transform lives, driven by a commitment to patients and a culture of collaboration, integrity, and excellence. We are dedicated to fostering an inclusive environment where diversity is celebrated, and professional growth is encouraged. While we recognize that candidates may not meet every qualification, we welcome applicants who are eager to contribute their talents and grow with us. Joining Sobi means becoming part of a team that values work-life balance, competitive compensation, and the opportunity to create a lasting impact in the healthcare industry.

Role Overview

The Compliance Operations Manager for the GCC region will serve as a pivotal operational partner within the MENAT Compliance function, ensuring the effective implementation and execution of Sobi’s Compliance Program across GCC markets. This role is designed to uphold operational compliance excellence, prepare for audits and inspections, manage third-party risks, maintain robust documentation governance, and provide compliance monitoring. The position will collaborate closely with Commercial, Medical, Market Access, Regulatory, Supply Chain, Finance, distributors, and third-party partners to ensure business operations remain compliant while fostering a culture of integrity, accountability, and proactive risk management. Reporting to the Compliance Director MENAT, this role will strengthen local execution, enhance responsiveness, and support regional strategic initiatives, governance, and transformation efforts.

Key Responsibilities

Compliance Operations & Business Support

• Act as the primary point of contact for day-to-day compliance guidance across GCC markets, providing clear and practical support to business teams on policies, procedures, and compliance requirements.
• Drive the implementation of global and regional compliance initiatives, ensuring alignment with Sobi’s standards and local regulatory frameworks.
• Champion a culture of ethics, transparency, and accountability, embedding compliance principles into daily operations.
• Escalate significant compliance matters to the Compliance Director MENAT in a timely and structured manner.

Audit Readiness & Documentation Governance

• Lead affiliate and distributor audit readiness activities, ensuring all compliance documentation is complete, organized, and inspection-ready.
• Track and follow up on corrective and preventive actions (CAPAs) to ensure timely resolution and continuous improvement.

Third-Party Risk Management (TPRM)

• Coordinate and oversee third-party due diligence activities across GCC markets, including distributors, vendors, consultants, service providers, and patient organizations.
• Support risk assessments to evaluate the compliance posture of third parties and identify potential risks.
• Monitor due diligence renewals and conduct ongoing risk reviews to maintain compliance standards.
• Ensure all TPRM documentation and records are accurately maintained and readily accessible.

Monitoring & Compliance Oversight

• Conduct compliance monitoring activities in accordance with approved monitoring plans, identifying trends, gaps, and opportunities for improvement.
• Prepare comprehensive monitoring reports and follow-up actions to address identified risks.

Regulatory Intelligence & Local Compliance Updates

• Monitor and analyze relevant GCC healthcare compliance developments, including changes in local regulations, industry codes, and SFDA requirements.
• Prepare periodic compliance intelligence updates to inform stakeholders and support proactive risk mitigation.

Distributor & Vendor Compliance Oversight

• Support the governance, reviews, and oversight of key distributors and high-risk third parties to ensure compliance with Sobi’s standards.
• Monitor compliance commitments and action plans, ensuring timely implementation and follow-through.
• Collaborate on distributor training and awareness initiatives to enhance compliance awareness and adherence.

Compliance Committee & Governance Support

• Coordinate local compliance governance meetings, ensuring structured discussions and actionable outcomes.
• Track action items and follow-up activities to drive accountability and timely resolution.
• Prepare compliance dashboards, metrics, and reports to provide transparency and insights to leadership.

Qualifications & Experience

To excel in this role, candidates should possess a bachelor’s degree in a relevant field such as Business Administration, Law, or Healthcare, complemented by a minimum of 5-7 years of experience in compliance, regulatory affairs, or a related field within the pharmaceutical, healthcare, or life sciences industry. Strong knowledge of GCC regulatory frameworks, including SFDA requirements, is essential. Experience in third-party risk management, audit readiness, and compliance monitoring is highly desirable. The ideal candidate will demonstrate exceptional analytical, organizational, and communication skills, with the ability to influence stakeholders at all levels. Proficiency in English is required, and additional language skills in Arabic are a plus. A commitment to ethical business practices and a passion for improving patient outcomes in rare diseases will be key to success in this role.