QA Manager / Deputy Responsible Person

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

The Affiliate Deputy Responsible Person & QA Manager 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, 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 at the affiliate from receipt of final product through distribution are in compliance with corporate, governmental, and local regulations and requirements.

• University Degree in Pharmacy or Biotechnology
• 3+ 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, Manufacturing Operations. 
• Knowledge and familiarity with product, process, and both internal and external customer requirements.
• Comprehensive knowledge of national and EU GDP legislation
• Knowledge of Quality 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

Responsibilities:

• Responsible for compliance with all local and corporate legal provisions applicable to the activities carried out.
• Responsible for obtaining, maintaining, and complying with the provisions of the distribution authorization and other needed authorization.
• Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Responsible for implementation, maintenance, and improvement of the quality system.
• Assist with the integration and support of quality regulations: drug, biologics, device and/or combined 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.
• Execute quality plans and provide assistance to the various multi-disciplinary departments and teams with respect to planning and execution.
• 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.
• Represent affiliate QA in regional, global, and cross functional teams, projects, and programs, as assigned by management.
• Responsible for the quality of products released onto the market.
• Responsible for compliance with reporting deadlines to the competent authorities in accordance with the legal provision and the correctness of the reported data.
• To act as Responsible Person and fulfill duties as laid out in cGDP Regulations and AbbVie Global Procedures.

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html