Purpose

Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to: Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities.

Responsibilities

• Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Ability to analyze current processes and information obtained and make decisions for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations.
• Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Responsible for CAPA and Non-Conformance program for Global Product Surveillance.
• Oversees development of departmental metrics for AbbVie’s local and segment management reviews and ad hoc requests.
• Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies.
• Assess opportunities for interdepartmental and site harmonization of practices and interruption of quality system requirements.
• Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.).
• Provide generalized Quality System, company, departmental and product knowledge as required.
• Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers.
• Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization.
• Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews.