Third Part Manufacturer & Technical Transfer QA Manager – METAP & CIS

This position works out of our Pakistan, Karachi in the Established Pharmaceutical division (EPD).

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 Management and Product Transfer, Technical Support for Middle East, Africa, Turkey, Pakistan and CIS.

What You’ll Do

Regional TPM Quality:

• Primary responsible for Quality management related to TPM in the METAP&CIS region, for delivering quality products through reliable supply chain.
• Primary responsible for development of Quality Improvement Plan for TPMs remediations, when required.
• To coach and mentor TPMs and suppliers for implementing effective quality systems to maintain compliance.
• Responsible of Monitoring TPM quality performance.
• Primary lead for Quality Technical Agreements approval 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 representing regional TPMs and Suppliers Quality in Management Review.
• Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied for METAP&CIS region
• Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
• Primary QA interface for new contract manufacturing site approvals within METAP-CIS region must approve all new contract manufacturers for EPD commercial product within responsibility.

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.

This position requires extensive travelling up to 40%.