Core Job Responsibilities:

　　The Senior QA Specialist is responsible for providing quality assurance support for quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This role will be covering the Hong Kong affiliate (including Macau).

　　Quality Assurance

　　 Provides functional and strategic leadership and direction to the Affiliate Quality organization to ensure that business and quality objectives are met.

　　 Design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.

　　 Develop, manage and implement quality principles to ensure effective compliance of the affiliate quality system with AbbVie policies, processes and procedures and all applicable regulations and industry standards, including establishment and maintenance of local procedures, work instructions, records and all applicable quality system documents.

　　 Coordinate and investigate quality events such as deviations, nonconformities, complaints, and corresponding action plans including decisions on personnel assignments to assure continuous improvement of product and quality systems.

　　 Overlook affiliate redressing activities (e.g. overlabeling, redressing) to ensure compliance with requirements and minimize risks.

　　 Managing internal and external quality inspections and audits (including reporting, response to observations and tracking of action plans).

　　 Support supplier qualification program for the affiliate including audits, quality agreements and performance monitoring.

　　 Quality management of medical devices (e.g. vaporizers)

　　 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 shipments.

　　 Coordinate and support of all activities related to product actions (recalls, withdrawals, corrections, etc.) in the affiliate, in the affiliate, in collaboration with affiliate Regulatory Affairs and General Manager.

　　 Coordinate the Management Review process for the affiliate.

　　 Coordinate quality training program: develop and implement quality system training to ensure compliance with identified quality goals and standards and that promotes the highest level of quality and compliance.

　　 Responsible for establishing and carrying out a quality self-inspection program within the affiliate.

　　 Communicate with internal and external customers on all quality and compliance-related matters.

　　 Evaluate, analyze, and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.

　　 Ensure metrics and KPIs are being met.

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

　　 Represent affiliate QA in regional, global, and cross-functional teams, projects and programs, as assigned by management.

　　Key Stakeholders

　　Local Affiliate Staff, Commercial Team, Regulatory Affairs, Medical, Pharmacovigilance, Commercial QA team, National Regulatory Authority, Suppliers/Service Providers

　　• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, or other technical/scientific area preferred.

　　• Minimum 3 to 5 years’ experience in quality assurance, or relevant experience.

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

　　• Knowledge of applicable regulations, QA systems and GxP compliance requirements including regulations and standards affecting medical device, biologics and pharmaceutical products preferred.

　　• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

　　• Experience working in both teams setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.

　　• Strong oral and written communication skills needed. Proficiency in English and local language.

　　• Excellent interpersonal skills and negotiation skills.

　　• Strong computer skills and knowledge of enterprise systems such SAP, SolTraqs, GTW etc.

　　• Ability to assess and comprehend issues, then present solutions in a logical format.

　　• Proactive approach.

　　• Execute projects and deliver tactical and strategic results.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.