Job Title: Compliance Director
About the Role:
We are seeking a seasoned Compliance Director to join our team and drive quality compliance initiatives forward. As a key member of our organization, you will be responsible for ensuring our Quality Management System is robust, inspection-ready, and compliant with global regulatory requirements.
This role involves providing strategic leadership and operational oversight for quality systems, risk management, training, and product complaint processes. You will maintain a deep understanding of global regulatory standards, including 21 CFR Part 11 and EU Annex 11, and ensure our electronic Quality Management System (eQMS) is validated, integral, and compliant.
In this capacity, you will oversee documentation management, data integrity, and change control processes. Your expertise in risk management, product complaints, and CSV will be invaluable in driving our quality compliance agenda forward.
To succeed in this role, you will need strong leadership, project management, and problem-solving skills. A proven track record of communicating complex compliance topics effectively to stakeholders at all levels is essential.
Key Responsibilities:
* Maintain a robust and inspection-ready Quality Management System (QMS)
* Oversee the validation, integrity, and ongoing compliance of electronic quality systems
* Ensure procedures are appropriately authored, reviewed, approved, and updated
* Manage the Documentation Management System and ensure all controlled documents meet regulatory standards
* Maintain compliant training records and quality documentation in alignment with regulatory expectations
* Lead the development and implementation of a GxP training program for relevant personnel
* Support the development and tracking of quality metrics and key performance indicators (KPIs)
* Provide governance and facilitate Quality Risk Management processes, including timely escalation to senior leadership
* Lead continuous improvement initiatives for quality systems and processes
* Oversee Change Control processes to ensure systematic and compliant change implementation
* Manage the Product Quality Review (PQR) and Product Complaint programs, including investigations and Corrective and Preventive Actions (CAPAs)
* Oversee the Computer System Validation (CSV) program ensuring compliance with 21 CFR Part 11 and EU Annex 11
* Serve as a primary quality compliance liaison with cross-functional departments
Requirements:
* Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, or a related field
* Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment
* In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems
* Strong expertise in risk management, product complaints, change control, and CSV
* Proven ability to communicate complex compliance topics clearly to stakeholders at all levels
* Excellent leadership, project management, and problem-solving skills