Quality Assurance Specialist

The Role

We are looking for a Quality Assurance Specialist to operate and maintain a compliant local Quality Management System (QMS) across our Latin American affiliate territory. In this role, you will be the quality representative for CSL Behring within your country of responsibility, ensuring full compliance with local regulatory requirements and global company standards. You will work closely with the Regional Quality Officer (RQO) and cross-functional partners to uphold the highest quality standards across our product lifecycle.

What You Will Do

Quality Management System (QMS)

• Maintain and implement the local QMS in compliance with local regulations and CSL Behring global standards.
• Manage core QMS processes including Deviation Management, CAPA, Product Complaints, Change Control, Documentation, Training, Recall, Self-Inspection, and Quality Risk Management.
• Monitor quality KPIs and recommend continuous improvements to support business operations.
• Archive and maintain all quality documents in accordance with CSLB procedures and applicable legal requirements.
  
  

Batch Release & Product Management

• Perform final administrative release of all product batches in SAP, ensuring all documentation meets local/regional requirements.
• Manage product returns efficiently and determine final disposition of returned products.
• Ensure only qualified GMP/GDP-compliant suppliers, vendors, and customers are utilized.
  
  

Recalls & Field Actions

• Act as Affiliate Recall Coordinator; execute recall operations per CSLB procedures and local regulations.
• Coordinate with marketing authorization holders and national competent authorities during recall events.
• Support field actions as directed by the Supply Chain Incident Management Team (SCIMT).
  
  

Audits & Inspections

• Support and participate in corporate and regulatory audits; assist in audit preparation and development of CAPA plans.
• Ensure continuous inspection readiness across affiliate operations.
  
  

Supplier & Distributor Oversight

• Provide oversight of 3PL vendors; support qualification, selection, and onboarding of new suppliers.
• Maintain up-to-date Quality Agreements with relevant partners.
  
  

Regulatory & Cross-functional Collaboration

• Act as deputy contact point to the RQO for reporting quality-related supply chain issues to local regulatory agencies or distributors.
• Support new product launches and ensure lifecycle compliance for existing products.
• Contribute to global and above-market quality projects as assigned; serve as subject matter expert on transactional quality tasks.
  
  

Laboratory & Analytical Support (where applicable per affiliate scope)

• Perform quality control tests in accordance with established methods and GMP regulatory guidelines; properly document all test results.
• Ensure laboratory instruments are qualified, calibrated, and maintained in compliance with cGMP standards.
• Evaluate analytical instrument performance; recommend new acquisitions or replacements as needed.
• Author protocols and reports for suitability studies and investigations supporting testing and compliance activities.
• Assist in the development of new test methods and maintain standard operating procedures (SOPs).
• Document quality issues and performance measures for management review.
  
  

What You Bring

Education

• Bachelor's degree in Pharmacy, Life Sciences, Biology, Microbiology, Chemistry, or a relevant scientific discipline (or as required by local legislation).
• Fluency in English and Spanish
  
  

Experience

• Minimum 3 years of experience in the pharmaceutical industry, including at least 1 year in Quality Management Systems.
• Solid working knowledge of GDP, GMP, and applicable local and international regulations.
• Hands-on experience with pharmaceutical quality assurance systems and compliance processes.
  
  

Skills

• Fluent in local/regional language(s); strong oral and written English communication skills.
• Sound, balanced judgment with the ability to assess and manage quality risks.
• Proactive, self-confident, and decisive — able to operate independently under general supervision.
• Strong cross-functional collaboration skills; able to work effectively with affiliate teams, global functions, and external partners.
  
  

Note On Local Requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.