Quality Assurance Compliance Manager

Summary:

The Compliance QA Manager – Systems is responsible for overseeing and maintaining Quality Management Systems (QMS) to ensure effectiveness, compliance, and continuous improvement across GxP functions. This role provides system administration, user support, and quality oversight for validated applications and computerized systems.

Key Responsibilities

• Support QA Partners by analyzing user enhancement requests and delivering process-improving solutions.
• Gather and document user and functional requirements; support implementation plans and project timelines.
• Perform system testing activities, including UAT, PQ, and validation activities.
• Administer day-to-day system operations: access management, change control, configuration, issue resolution, and report creation.
• Maintain system documentation and end-user support materials.
• Review and approve validation deliverables (URS, FS, IQ/OQ/PQ).
• Author and review CSV/DI policies, procedures, and lifecycle documentation.
• Track data quality metrics and support continuous improvement initiatives.
• Support internal and external audits/inspections.
• Maintain integrations with systems such as LMS platforms (e.g., ComplianceWire), as applicable.

Qualifications

• Bachelor’s degree in a scientific or related discipline with 7 years of relevant experience, or equivalent combination of education and experience.
• Minimum 5 years working with validated applications in a regulated or pharmaceutical environment.
• Hands-on experience implementing and maintaining GxP computerized systems.
• Strong understanding of quality and regulatory processes.
• Proven ability to deliver customer-focused technology solutions.
• Excellent communication skills with both technical and non-technical users.
• Experience with Veeva Quality Suite (QMS, QDocs) and other regulated applications.
• Working knowledge of SaaS systems, databases, and general computer networking.
• Strong process improvement mindset and collaborative approach.