Quality Systems Specialist

Reporting to the Sr Director, Quality Systems, the Quality Systems Specialist will support and provide oversight of quality system-related activities for internal and external operations in areas such as Deviation/CAPA, Change Controls, Quality Management Review and Monthly Metrics, Supplier Notification of Changes, Deviation and CAPA. Demonstrated experience work within Change Control, Deviation and their associated CAPAs, Investigations, Supplier Notification of Changes and Supplier Corrective Actions Requests a plus.

Reporting to the Sr Director, Quality Systems, the Quality Systems Specialist will support and provide oversight of quality system-related activities for internal and external operations in areas such as Deviation/CAPA, Change Controls, Quality Management Review and Monthly Metrics, Supplier Notification of Changes, Deviation and CAPA.

Responsibilities:

• Actively partners with the Global and Site Leadership Teams to support adherence to the Quality Management System principles, company projects and other activities. Informs senior management of critical issues.
• Support compliant quality systems, including but not limited to change control, investigations, deviations, CAPA, and Audit readiness
• Coordinate revisions of associated SOPs, forms, and templates for the Quality Systems.
• Supports the monitoring of weekly quality metrics as well as the quarterly metrics to support the Quality Management Review process. Assist in a ensuring a state of control by driving actions to resolve current or potential issues as appropriate.
• Provide guidance to the user community by supporting or managing deviations, investigations, changes, risk assessments and CAPAs.
• Work effectively and collaboratively with local and global cross-functional teams, such as pharmaceutical development, manufacturing, quality control, regulatory affairs, and program management.
• Manage competing priorities to meet departmental and organizational targets and timelines
• Promote a culture of quality and operational excellence.
• Other activities as per request.

Requirements/Qualifications:

• A bachelor’s degree in a scientific discipline required.
• 1-3 years of experience in pharmaceutical / medical device industry.
• Demonstrated experience with working in effective cGMP quality systems, inclusive of writing SOPs. 
• Demonstrated experience work within Change Control, Deviation and their associated CAPAs, Investigations, Supplier Notification of Changes and Supplier Corrective Actions Requests a plus.
• The ability to work in a fast-paced, start-up environment autonomously
• Strong collaboration, teamwork, organizational skills at attention to detail
• Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders
• GMP knowledge and experience required, GLP and GCP considered a plus.