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.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.