AbbVie Associate QA Manager in Shanghai, China
Associate QA Manager
China, Shanghai, Shanghai
Requisition # 1906521
The Affiliate QA Manager is responsible for providing 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 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 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.
Key Responsibilities Include:
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.
Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
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.
Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (i.e. 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.
Responsible for deploying /upgrading SOPs，assure GxP related SOP implementation in affiliate China
Responsible for new creation of mater data review and approval in GSP system
Bachelor’s Degree in Chemistry, Pharmacy, Biology, other technical/scientific area.
2-4 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred.
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 at all levels.
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.
Strong decision making skills.
Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache and Attache Pro.
Job Type: Experienced
Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.