Sr. Manager, Quality Systems

Work Location: Middlesex County, Massachusetts

Summary:

The Sr. Manager, Quality Systems is responsible for overseeing and enhancing the electronic Quality Management System (eQMS), ensuring compliance with regulatory requirements, and supporting document control and training processes. This role involves system administration, process improvement, user support, and collaboration with cross-functional teams to drive quality initiatives and maintain inspection readiness.

Responsibilities:

• Oversee the configuration, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure regulatory compliance and effective document control.
• Lead the technical development, implementation, and enhancement of scalable eQMS modules, including project management, validation, and user training activities.
• Manage the full lifecycle of eQMS applications, collaborating with internal stakeholders to support design, release, change control, upgrades, and retirement processes.
• Drive harmonization and optimization of eQMS workflows, streamline business processes, and support all phases of the product development lifecycle.
• Develop and deliver user support materials, training content, and standard operating procedures to enable effective system utilization across the organization.
• Monitor and report on the effectiveness of eQMS enhancements, ensuring communication, training, and adoption of new features and processes.
• Establish and maintain Quality Systems metrics, dashboards, and analytics to support management oversight, compliance, and continuous improvement initiatives.
• Support regulated training curricula management, document control processes, and inspection readiness activities, including participation in regulatory inspections and system demonstrations.

Qualifications:

• Bachelor's degree required.
• 7+ years of experience in Quality Systems, eQMS administration, or Document Control within biotechnology, pharmaceutical, or life sciences industries.
• Experience administering electronic QMS and/or Learning Management Systems; familiarity with platforms such as ZenQMS, MasterControl, Veeva Quality, ComplianceQuest, or TrackWise preferred.
• Proficiency in IT project and change management, especially in cGMP and GCP regulated environments.
• Strong knowledge of software lifecycle management, change control, computer system validation (CSV), and system implementation.
• Experience with software tools for creating computer-based learning content (e.g., Camtasia, Captivate) preferred.
• Background in implementing Quality System solutions supporting GMP, GCP, and/or GLP environments.
• Demonstrated ability to develop Quality Systems metrics, dashboards, and process analytics.
• Technical proficiency in administering eQMS software platforms and managing electronic document management systems.
• Experience supporting user acceptance testing, workflow design, system configuration, validation documentation, and release management preferred.
• Strong project management skills and ability to manage multiple priorities and cross-functional initiatives.
• Excellent written and verbal communication skills.
• Ability to adapt to organizational change, collaborate in a matrix environment, and navigate ambiguity.
• Experience developing and delivering training materials, both instructor-led and electronic.
• Expertise with validated systems and successful project delivery from requirements gathering through implementation.
• Ability to apply regulatory requirements and industry best practices in regulated training and Quality Management Systems.
• Demonstrated subject matter expertise in Quality Systems and ability to provide technical guidance to business partners.
• Experience driving process improvements through workflow optimization, automation, and technology-enabled enhancements.
• Strong critical problem-solving skills and ability to coordinate complex Quality Systems initiatives.
• Ability to interact effectively at all organizational levels and work independently with sound judgment.
• Capacity to balance short- and long-term priorities in support of business objectives.
• Commitment to continuous improvement and staying current with regulatory requirements, industry trends, and best practices in Quality Systems.

Published Category: Quality & Validation