For a pharmaceutical company, eTalent solutions is looking for a

QA Manager for Third-Party Manufacturing and Tech Transfer

Responsibilities: 

• Providing QA support to Third-Party Manufacturers (TPMs) and Suppliers to ensure compliance with cGMP and regulatory standards.
• Developing Quality Improvement Plans for TPM remediations when necessary.
• Managing TPM and Supplier activities with a focus on continuous improvement.
• Monitoring quality performance and ensuring adherence to Quality Technical Agreements by TPMs and suppliers.
• Leading approval and renewal of Quality Technical Agreements.
• Serving as the primary contact for TPM Quality issues.
• Providing QA support for investigations, complaints, CAPA, validation, and product release.
• Maintaining the regional Approved Supplier Listing.
• Communicating with Global TPM/Supplier QA regarding products supplied to the region.
• Supporting Global and Regional Quality Compliance and improvement initiatives.
• Leading QA activities during Product Technology Transfers, including Change Control, Validation, and Process Validation.
• Participating in regulatory documentation creation and improvement for EPD products.
• Ensuring compliance and quality standards for Drug Substances, Drug Products, and other non-pharma products.
• Acting as a liaison between QA, commercial affiliates, and other relevant groups during technical activities.
• Serving as a Regional NPI Coordinator for Geo-Expansion and other projects.
• Acting as a quality technical resource for EPD Quality during process and regulatory issues and improvement initiatives.

Required Qualifications:

• Educational Background: Bachelor’s degree in science, Pharmacy, or equivalent in a relevant scientific discipline.
  
• Experience: Minimum 5 years of experience in pharmaceutical manufacturing fields such as Quality, production, or technical support.
  
• Knowledge Base: Comprehensive understanding of Pharmaceutical Manufacturing and Testing Operations, including GMP/GLP/GCP standards for medicinal products, medical devices, and food supplements. Familiarity with Biotechnological, Biosimilars, and Biologics is a plus.
  
• Language Skills: Proficiency in French, English, and Arabic with strong communication and report writing abilities in all three languages.
  
• Leadership and Teamwork: Demonstrated strong leadership skills to manage teams effectively and foster teamwork within the department.
  
• Strategic Skills: Strong strategic planning, decisive judgment, and implementation skills.
  
• Travel Flexibility: Willingness and ability to travel up to 20% of the time.