Sr. Manager, Quality Systems

Responsibilities

• Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Quality Metrics, and other core QMS programs.
• Lead or support the implementation, configuration, validation, and optimization of the electronic Quality Management System (eQMS), ensuring phase-appropriate design and scalability.
• Provide hands-on expertise in the day-to-day execution, review, and management of QMS records within the eQMS.
• Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for quality systems.
• Ensure data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations (e.g., ALCOA+ principles).
• Monitor overall quality system effectiveness, identify gaps or inefficiencies, and drive continuous improvement initiatives.
• Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness.
• Develop, compile, analyze, and present quality metrics and KPIs for routine management review.
• Perform trending and data analysis to identify risks, systemic issues, and opportunities for improvement.
• Create and deliver training programs related to QMS processes, data integrity, and eQMS functionality.
• Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal quality standards.
• Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and quality ownership.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance.
• Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management.
• Strong working knowledge of quality system data management, reporting, and data integrity principles.
• First-hand experience managing and reviewing deviations, investigations, CAPAs, and change controls in a regulated environment.
• Experience using validated computerized systems to manage regulated quality records.
• Proven ability to develop and implement enhancements to electronic Quality Systems to improve usability, compliance, and reporting.
• Strong proficiency with Microsoft Office Suite and related business applications.
• Ability to manage multiple priorities in a fast-paced, evolving environment with strong attention to detail.
• Highly organized, self-motivated, and capable of working independently while effectively collaborating cross-functionally.
• Excellent written and verbal communication skills, with the ability to influence and interact effectively at all levels of the organization.