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Regional Quality Assurance Manager
hace 4 meses
At AbbVie we are lookink for The Regional QA Manager, in this position you will be 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, combination products and biologics.
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 are in compliance with Corporate, governmental, and local regulations.
Responsibilities:
- Responsible for 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 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 affiliate.
- Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.
- Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
- Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (ie. CAPA, product complaints) ensuring KPIs are being met.
- Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
- Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.
- Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
- Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.
Qualifications:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, other technical/scientific area, MBA or M.S. preferred.
- Minimum 5 years experience in quality assurance, operations, regulatory or relevant experience. Min 2 years Management experience.
- 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.
- Strong influencing, motivational, interpersonal and relationship building skills with staff and at all levels.
- Ability to make opertational and business decisions with mínimal direction.
- Excellent written and oral communication skills. Proficiency in English.
- Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
- Negotiation skills, effective collaboration and ability to anticipate needs and requirements, managing matrix teams.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro.
