Quality Compliance Manager

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

The Quality Compliance Manager is accountable for developing, managing, and continuously improving the organization’s quality compliance strategy and systems to ensure full alignment with global regulatory requirements (e.g., FDA, EMA, WHO, GMP) and internal EDA quality standards. This leadership role drives audit readiness, risk mitigation, and quality culture across the organization, ensuring that processes, documentation, and operations consistently meet or exceed regulatory expectations.

The job holder will be based in our site in Cairo, al Obour City and reporting to the Site Quality Head.

Your responsibilities:

Develop and lead the site-wide compliance strategy, ensuring alignment with regulatory requirements (EDA, FDA, EMA, MHRA, ICH, WHO, GMP, GDP) and corporate quality policies.

Establish, implement, and monitor compliance programs, policies, and procedures that support continuous inspection readiness and sustainable regulatory compliance.

Assure that internal audits, risk assessments, and gap analyses across departments are satisfactory; ensure effective closure of findings and implementation of corrective and preventive actions (CAPAs).

Oversee external audit and regulatory inspection readiness, acting as the primary site contact for regulatory authorities and certification bodies.

Advise senior leadership and cross-functional stakeholders on compliance risks, mitigation strategies, and regulatory updates with potential operational impact.

Oversee the effectiveness and timeliness of CAPA investigations and closures per applicable standards (WHO, ISO, FDA).

Manage and approve quality-impacting systems; ensure cross-functional evaluation and regulatory alignment.

Manage and assure the site audit readiness.

coordinate with internal and external stakeholders to ensure resolution and compliance.

Ensure that departments are audit-ready and aligned with data integrity principles.

Lead and develop a high-performing compliance team, ensuring proper requirements, development plans, and succession readiness.

Support quality governance and management review processes by providing compliance metrics, risk reports, and continuous improvement initiatives.

Lead QC compliance in terms of all CQAs

Lead Quality Council for all Technical departments KPIs

Qualifications and Experience:

Bachelor’s degree in pharmacy (mandatory).

Minimum 15 years of pharmaceutical Quality Assurance experience.

Strong experience in GMP, GDP, and global regulatory requirements (FDA, EMA, MHRA, ICH, WHO).

Proven expertise in compliance strategy, audits, CAPA management, and inspection readiness.

Experience managing and developing compliance or QA teams with strong leadership skills.

Excellent analytical, problem‑solving, documentation, and communication abilities.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!