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About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

TPM & Supplier QA Manager -METAP

PRIMARY JOB FUNCTION

The TPM & Supplier Senior Manager is responsible for providing QA support for assigned TPM’s and/or Suppliers to ensure that safe, efficacious and quality product can be supplied to Abbott METAP region to meet cGMP and other applicable regulatory standards and the appropriate market requirements.

Job holder will be ensuring required support is provided to ensure smooth execution of new contracts signed with partners for Abbott portfolio expansion through addition new products in the pipeline by L&A deals or the new localization projects within METAP region for price protection. Job holder will be Leading crucial investigations for critical complaint posing risk of recall or which could damage patient health together with cross functional team and third party manufactures under high time pressure. The jobholder should use analytical thinking and decision-making strategy to select the best benefit to the company and business. The jobholder should be with high technical knowledge and skills to unlock new areas and constructively discuss with the partner and should have influential skills.

Job Responsibilities-

• Quality management and oversight at TPM and Supplier in the METAP region, for delivering quality products through reliable supply chain with on-site visits on set frequency and business needs
• Responsible to support establishing and implementing Management Processes at Third Party and supplier of raw materials, medicinal products, medical devices & consumer health products per Regulatory & Abbott EPD contractual requirements.
• QA Lead in the New product Introductions meetings and localization projects for smooth execution and launches from contract manufacturing sites from product acquisition, in-licensing deals and or distribution deals.
• Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliers
• QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM and supplier sites
• QA lead for co-ordination with TPMs & Supplier and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
• Primary Contact for communication / resolution of TPM & supplier Quality issues and management elevation as needed.
• Responsible for updation and maintenance of regional approved supplier listing.

Required qualification:

Bachelor’s degree in science; Pharmacy or microbiology or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with enough exposure to pharmaceutical or related industries.

Experience:

• Total combined years: 10+ years in QA, Operations or Pharmaceutical engineering. Minimum 5 years of experience in Quality Assurance / Quality Control function / department.
• Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
• Knowledge of international and local quality system and compliance legislations and standards
• Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid and injectable products.
• High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices

Principle Challenges

Faces assignments that vary with differing procedures that allow choices from a few solutions. Situations are fairly-similar, and the solution can usually be found with some effort

Language preference:

English is must. French and Arabic are desired.