The Opportunity – Third Part Manufacturer and Technical Transfer QA Manager– METAP&CIS

This position works out of our Saudi Arabia affiliate in the Established Pharmaceutical division (EPD) and is part of METAP& CIS Region (Middle East, Africa, Turkey, Pakistan & CIS).

Established Pharmaceuticals 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 Third Part Manufacturer and Technical Transfer QA Manager, you’ll be responsible for TPM QA Management and Product Technical Transfer.

What You’ll Do

Regional TPM Quality:

• 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.
• Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
• Managing TPM & Supplier activities while driving continuous improvement for TPMs and Suppliers.
• Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliers.
• Leading Quality Technical Agreements approval and renewal
• Primary contact for communication of TPM Quality issues as needed.
• QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
• Responsible for maintaining regional Approved Supplier Listing.
• Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied for Saudi.
• Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
• Support new contract manufacturing site approvals within METAP-CIS region must approve all new contract manufacturers for EPD commercial product within responsibility.
• 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 to achieve regional and affiliate goals.

Product Transfer and Support QA

• QA Lead for below quality activities during Product Transfer and ASQ including,
  • Change Control / Stability and Change Impact Assessment
  • Test Method Transfer/Analytical Method
  • Validation/Verification
  • Process Validation/Verification Program
  • Stability program during Shelf-Life of the product Microbiological validation studies
  • First lot quality review for release the validation batches for commercialization.
  • Gather information from the Sending Unit, in order to assemble a data package.
  • Evaluate the information gathered and document findings with respect to product robustness
• Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.
• Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues
• Involve in support the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.
• Supporting the lifecycle management strategy and supporting its operational execution as supporting the work-stream team or equivalent cross-functional team. Managing product and process quality and compliance throughout the maturity stage of the life cycle of EPD commercialized products
• Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
• Contribute to the final decision making on the usage of new Third-Party Manufacturers (TPMs) within the EPD division. Provide Quality Leadership in the Regional EPD team structure.
• Liaison between sites QA, commercial affiliates, MS&T (Manufacturing Science and Technology) and other groups as necessary.
• Act as Regional NPI Coordinator for Geo-Expansion, L&A (License and Acquisition) and different project.
• Conduct/assist in due-diligence audits for new API suppliers to provide a rapid and accurate usage decision on proposed suppliers
• Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives.

Required Qualifications

• Bachelor’s degree in chemistry, Pharmacy, Medical Science.
• 8+ years of supervisorial experience in the pharmaceutical (Quality, Production, R&D etc.) or related fields.
• GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics
• Good communication and report writing skill in English and Arabic.
• Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
• Strong strategic Planning/ Thinking, decisive judgement, and Implementation skills.
• Flexible for Travel: 40 %