Manager, Global Quality Management System (QMS)

Essential Duties & Key Responsibilities

• Lead and manage the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
• Oversee the global internal audit program, including planning, execution, reporting, and tracking of corrective/preventive actions.
• Own the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP requirements.
• Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and other health authority inspections.
• Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
• Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
• Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
• Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems (e.g. MasterControl, ERP systems, Trackwise, etc.) ensuring alignment with regulatory and internal requirements.
• Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.
• Represent the Quality organization in interactions with external auditors, suppliers, and regulatory agencies as required.

Minimum Experience, Education, Certifications, Licenses

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.
• Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
• Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
• Demonstrated success in establishing and trending quality performance metrics and KPIs.
• Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
• Experience working in a multi-site or global quality organization strongly preferred.
• Excellent organizational, analytical, and communication skills, with the ability to influence and collaborate across functional and site boundaries.