Quality Assurance Manager

3 weeks ago

جدة, Saudi Arabia AbbVie Full time

**Company Description**

Purpose:
The Affiliate QA Manager is responsible for implementing a robust quality management system at the affiliate along with providing quality assurance support to affiliate functions ensuring quality system requirements are properly fulfilled. The scope of responsibilities covers Legacy AbbVie and Legacy Allergan pharmaceutical products, medical devices, cosmetics, combination products and biologics. Specific areas of expertise include but not limited to: Quality Management System requirements, Storage and Distribution, Product Quality Complaints, potential quality events/product shortage management, Documentation Control, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements implementation. This position will ensure that all products, processes, or systems 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:

- Assist with the integration and support of quality regulations: drug, cosmetics, biologics, device and/or combination products.
- Assist in 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.
- 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.
- Partner, coordinate and support activities related to quality events (quality defects, security events, recalls etc) in the affiliate.
- Assist project teams in planning, preparation, review and approval of quality documentation.
- 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.
- Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance. Act as eLMS (Compliance Wire) administrator for the affiliate.
- Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions.
- Auditing suppliers and distributors through evaluation of performance monitoring prospective suppliers and distributors and re-evaluation in a timely manner and evaluation of sub-contracted activities impacting GDP
- Coordinate the Management Review process at the affiliate.
- Carry out quality Internal Audit program within the affiliate.
- Set and execute quality plans and provide assistance to the various multi-disciplinary departments and teams with respect to planning and execution.
- Ensure metrics and KPIs are being met.
- 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 and release of controlled temperature and cold chain shipments through reviewing of shipments temperature data for release and handling of temperature excursions.
- Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
- Customer revalidation including maintenance of exclusions and validation criteria
- Vendor Quality audits SOP training & induction trainings
- approval of any sub-contracted activities which may impact GDP
- Act as business partner and support the local business strategy (i.e. new product introduction)

**Qualifications**
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
- 5+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, and Manufacturing Operations.
- Knowledge and familiarity with product, process, and both internal and external customer requirements.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- 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.
- Proficiency in English.
- Excellent interpersonal skills.
- Strong computer skills and knowledge of enterprise systems such as Soleras, Cold Stream, Attaché, Attaché Pro, Word, Excel and Access.

Key Stakeholders:
AMT and Local Affiliate functions, Commercial Q

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