TPM/TT QA Manager

3 weeks ago


Jeddah, Makkah Province, Saudi Arabia Abbott Healthcare Products Ltd Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Abbott Healthcare Products Ltd. as a TPM/TT QA Manager. This is a critical role that will be responsible for ensuring the quality of our pharmaceutical products manufactured by third-party manufacturers and technical transfers.

Key Responsibilities
  • Provide QA support for assigned third-party manufacturers and suppliers to ensure compliance with cGMP and other applicable regulatory standards.
  • Develop and implement Quality Improvement Plans for third-party manufacturers and suppliers to address quality issues and improve overall quality performance.
  • Manage third-party manufacturer and supplier activities, driving continuous improvement and ensuring compliance with quality standards.
  • Monitor quality performance for assigned third-party manufacturers and suppliers, ensuring adherence to quality technical agreements and regulatory requirements.
  • Lead the approval and renewal of Quality Technical Agreements with third-party manufacturers and suppliers.
  • Serve as the primary contact for communication of quality issues related to third-party manufacturers and suppliers.
  • Provide QA support for investigations, trends, complaints, corrective and preventive actions, validation support, and product release issues.
  • Responsible for maintaining the regional approved supplier listing.
  • Communicate with Global TPM/Supplier QA regarding global TPM products supplied for Saudi Arabia.
  • Support global and regional quality compliance and improvement initiatives.
  • Support new contract manufacturing site approvals within the METAP-CIS region.
  • QA lead for investigations, trends, complaints, corrective and preventive actions, validation support, product release issues, PQR review, and change control at third-party manufacturer and supplier sites.
  • QA lead for coordination with third-party manufacturers and suppliers and internal cross-functional teams for routine quality requirements.
Requirements
  • Bachelor's degree in chemistry, pharmacy, or medical science.
  • 8+ years of supervisory experience in the pharmaceutical industry or related fields.
  • GMP/GLP/GCP background related to medicinal products, medical devices, food supplements, biotechnological, biosimilars, and biologics.
  • Good communication and report writing skills in English and Arabic.
  • Strong leadership skills in bringing out the best in people, managing work teams, and fostering teamwork within the department.
  • Strong strategic planning/thinking, decisive judgment, and implementation skills.
  • Flexible for travel: 40%.

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