Purpose:

The Affiliate QA Manager will provide leadership and oversight of Quality Compliance matters at the commercial entity in support of quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics.

Specific areas include: Management Responsibilities, Product Quality, Process Performance, Documentation Management, CAPA and Change Management, Risk Management.

This position proactively ensures that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with corporate, governmental, and local regulations and requirements.

Responsibilities:

· Responsible for implementation of quality management system, defining obligations for wholesaling, procedures and processes and risk management measures. The integration and support of quality regulations: 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.

· Responsible for the management and oversight staff responsible for supporting of quality operations processes at the affiliate level.

· Responsible for the management and oversight of team 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.

· Assure key metrics are monitored and KPIs are being met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.

· Lead and oversee activities related to quality events (quality defects, security events, recalls etc.) in the affiliate. Oversee coordination and investigation of key quality systems such as deviations, non-conformances, CAPA’s, product complaints ensuring KPIs are met.

· Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.

· Represent affiliate QA in local, regional, global and cross functional teams, projects and programs. Partner with key stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward; deal with regulatory bodies, if required.

· Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. Responsible for establishing and carrying out a quality self-inspection program within the affiliate.

 · Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.

· To oversight management of customer complaints.

· Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements management and assessments.

· Coordinate the Management Review process at the affiliate.

· Develop and execute quality plans and provide guidance and assistance to the various multi-disciplinary departments and teams with respect to planning and execution.

· Coordinate change control process to ensure changes do not introduce negative impacts to operation.

· Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

· Monitor distribution quality activities at the Third-Party Logistics provider to ensure compliance with local and AbbVie requirements.

· Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.

· 5+ years’ experience in quality assurance, operations, regulatory or relevant experience.

· Some supervisory/management experience preferred.

· Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Distribution and Manufacturing Operations.

· Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.

· Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.

· Ability to work in both team setting and independently. Strong negotiation, influencing, motivational, interpersonal and relationship building skills at all levels. Ability to thing strategically.

· Strong decision making skills. Ability to make operational and business decisions with minimal directions.

· Excellent oral and written communication skills. Proficiency in English and the local language.

· Strong Computer skills.

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. 

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