Sr Quality Assurance Specialist

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 Commercial Quality Assurance (QA) Specialist is responsible for ensuring quality support for pharmaceutical products, medical devices, biologics, and cosmetics in Sweden . Key responsibilities include managing Quality Manual requirements, Supplier Controls, Risk Management, CAPA, and Agency inspections/internal audits. The Specialist ensures that all quality activities from product receipt to distribution comply with corporate, governmental, and local regulations. The Commercial Quality Specialist will also support the Scandinavian Commercial Quality team .  

Key Responsibilities include:  

•  

  Integrate local quality regulations for drugs, biologics, device/combination products, and cosmetics.  



•  

  Design quality systems, procedures, and processes to ensure compliance and efficiency.  



•  

  Assess compliance to processes, procedures, and regulations to identify potential gaps and implement improvements.  



•  

  Support internal, external, and MoH audits.  



•  

  Coordinate and investigate quality events and execute supplier qualification program.  



•  

  Monitor metrics and KPIs to ensure compliance.  



•  

  Represent Commercial Quality in cross-functional teams, projects, and programs.  




 
•  

Qualifications  

To be successful in this position we expect you to have a strong self-leadership, with at leas t 3+ years of experience within Quality Assurance, GMP or GDP environment and to be a strong team player.  

· Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.  

· Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire, and OneVault .  

· Full understanding of local GxP requirements and Medical Device regulations.  

· Ability to support projects as a team member or lead as assigned by manager.  

· Experience in working both in a team setting and independently.  

Key Stakeholders: Local Affiliate Staff, Commercial QA team, Regulatory/Competent Authority, Suppliers/Service Providers.  

Additional information  

This is a hybrid office-based role w h e re we offer our employees flexibility

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.