TPM-Supplier QA Manager

Job Title

TPM-supplier QA Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You Will Have Access To

• Career development with an international company where you can grow the career you dream of .
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

• This position works out of our Egypt affiliate in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
  
  

As the TPM-Supplier QA Manager, you’ll be 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-CIS region to meet cGMP and other applicable regulatory standards and the appropriate market requirements. And also 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-CIS 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.

What You’ll Do

• Manage TPMs and Supplier Quality activities in METAP-CIS region for TPMs for Lebanon, Egypt and Saudi Arabia
• Support new product launches, new product introductions, GeoEx of existing products from one country to another within METAP-CIS region with activation of new upcoming TPMs into METAP-CIS from portfolio growth.
• Support multi-regional suppliers supplying materials to Cairo and to other user sites within METAP-CIS or to other regions within EPD.
• Quality management and oversight at TPM and Supplier in the METAP-CIS region, for delivering quality products through reliable supply chain with onsite visits on set frequency and business needs.
• Managing TPM & Supplier activities while driving continuous improvement in department for TPMs and Suppliers.
• Responsible to support establishing and implementing Management Processes at Third Party and supplier of raw materials, medicinal products, medical devices & consumer health products.
• Quality representative for New product Introductions 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.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Coordinates across functional areas, business units, and/or geographies in order to achieve regional and affiliate goals.
  
  

Required Qualifications

• 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.
• Total combined years: Combined 15+ years in QA, Operations or Pharmaceutical engineering. Minimum 10 years in pharmaceutical manufacturing plant and 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
  
  

Preferred Qualifications

• 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.
• Other qualifications/certifications: IRCA Lead Auditor Certification, Auditor Certification Training, Complaint Certification , GMP-GDP Training. Highly skilled on cGMP requirements, team management, and Quality Assurance / Quality Control manager for solid and injectable products.
  
  

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.