Purpose:

The Affiliate Regional QA Manager is responsible for providing leadership and oversight of Quality Compliance matters across multiple areas in the affiliate considering therapeutics and aesthetics businesses in support of the quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics.  Specific areas include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, Lab Controls (as applicable), CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product including import testing activities are in compliance with Corporate, governmental, and local regulations. 

Provide support to Area affiliates to drive continuous improvement, accomplish KPIs and comply with local and external requirements.

Represents ABBVIE in the country (Mexico) in front of local Health Authorities.

Responsibilities

• Accountable for the integration and support of quality regulations within the affiliate: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Interact with LATAM team from another affiliates.
• Accountable for the management and oversight Quality Assurance (QA) and Quality Control (QC) teams across affiliate including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.  Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs. 
• Establish training requirements and maintenance of a diverse and agile cross trained and effective teams to ensure business continuity and compliance. 
• Lead and oversee support activities related to product actions in the affiliate.
• Assure key affiliate/regional metrics are being monitored (goals, CAPA, change plans etc.)  Use data and facts to make decisions and to pursue compliance/continuous improvement opportunities. Conduct management reviews as per plan.
• Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward. 
• Accountable for internal, external and MoH audits within the affiliate. Confidently knowing and understanding your affiliate/region’s business, licenses, distribution nodes, quality system applicability to support successful audits.
• Accountable for supplier qualification program including performance monitoring for key suppliers, QTA management and assessments. 
• Accountable for all activities governed by Good Storage and Distribution Practices, including monitoring of controlled temperature and cold chain shipments.
• Represent affiliate QA or act as a lead in regional, global and cross functional teams, projects and programs, as appropriate.    
• Accountable for representing ABBVIE in front of local Health Authorities in topics related to GMP assuming the responsibility for all products under ABBVIE MAH registration in the country.