Quality Assurance Affiliate Regional Manager (Brazil and Puerto Rico)

Your Role:

The Affiliate Regional QA Manager is responsible for providing leadership and oversight of Quality
Compliance matters across multiple commercial entities within a region 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 (Brazil) in front of local Health Authorities and Pharmacy Council.

You will be responsible for:

• Accountable for the integration and support of quality regulations within the region: 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.
• Accountable for the management and oversight Quality Assurance (QA) and Quality Control (QC) teams across multiple affiliates within a region 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 region.
• Assure key 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 region. Confidently knowing and understanding your region 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 in the regionincluding monitoring of controlled temperature and cold chain shipments.
• Represent affiliate QA or act as a lead in regional global and cross functional teams projects andprograms as appropriate.
• Accountable for representing ABBVIE in front of local Health Authorities and Pharmacy Council in topics related to GMP assuming the responsibility for all products under ABBVIE MAH registration in the country Brazil.

Qualifications :

Requirements: 

• Bachelors Degree in Chemistry Pharmacy Biology other technical/scientific area.
• 7 years experience in quality assurance operations regulatory or relevant experience preferred.
• 2 years management experience preferred.
• Full understanding of local GxP requirements with an indepth knowledge of some elements.
• General knowledge and understanding of AbbVie MD pharmaceutical biologic and cosmetic products and regulations how supplied therapeutic uses/indications strategic importance for the business and knowing how to get this information
• Ability to coach and develop others. Invests in people amplifies strengths to build the best talent
• Makes decisions with minimal direction (within scope of role)
• Excellence focused Drives results by focusing on prioritization and continuous improvement
• Influencing Understand your stakeholders and shape communication; can negotiate to win
•  Leading with presence Motivate their team build relationships and inspire followership
•  Business Acumen Knowing how QA connects to the broader business objectives We need to have an organization culture and team members that will push the envelope leaders that are embracing promoting and driving change
• Familiar with SAP TrackWise ComplianceWire OneVault
• Excellent written and oral communication skills. Proficiency in English.
• Key Stakeholders: Local Affiliate functions Commercial QA team Regulatory/Competent Authority
• Suppliers/Service Providers Product Quality Commercial Quality Systems Manager Global functions

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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