Month: December 2022

Functional Management

• Establish a Quality Management System (QMS) that will be in compliance with ICH Q10, EDA, WHO and EMA GMPs & GDPs and will ensure consistent and compliant manufacture, control and distribution of biological products, particularly vaccines.
• Design and implement a QMS in the company by either direct or matrix management with functional and site heads. As a part of the design stage :
  • Define the QMS requirements in coordination and agreement with the site and departmental functional heads
  • Take into account the specific requirements of Gennvax functions and activities
• Provide GennVax Senior and Quality Management with written and formal reports on Quality system implementation progress and performance plus any issues, on a regular basis, preferably monthly.
• Lead all activities, for the company, with respect to and relevant to compliance with the Gennvax QMS and with relevant Regulatory Agency and Recognised Industry Organisation Standards and Requirements.

• Establish and implement a Quality Management System (QMS) to cover all GennVax activities that may impact or be impacted, directly or non-directly, by GMPs, GDPs, the undertakings in regulatory submissions and other relevant guidance documents from regulatory agencies or industry bodies.

• Ensure that the Quality Management System has been correctly implemented by all Gennvax functions with all necessary procedures in place and staff appropriately trained in their operation.

• Establish Key Performance Indicators to track QMS implementation, performance and issues.

• Establish a programme of self-inspection audits to evaluate QMS and GMP compliance in all Gennvax functions and activities.

• Establish a programme of audits for all CMOs, CROs, Service Providers, Vaccine and API suppliers, Component Suppliers – primary and secondary and any company that provides key services and/or materials and/or products to Gennvax. Ensure that the frequency of auditing reflects the criticality of the materials/services provided to Gennvax

• Ensure that any areas of non-compliance are identified and appropriate corrective actions are defined and implemented.

• Monitor corrective action implementation and the results of effectiveness checks on completed CAPAs.

• Monitor the performance of the quality system through self-inspection, supplier and contractor audits, assessment of key performance indicators, trend analyses and annual product reviews. Ensure that the results of performance monitoring are provided in the regular Quality System and Compliance report to GennVax higher management

• Establish and implement a system for the management and archiving of controlled documentation.

• Interpret regulatory requirements in a realistic and practical manner and provide clear guidance to Gennvax functions on how to ensure compliance with them

• Review all documents relating to activities that may impact MS and GMP compliance and product quality, including but not limited to batch manufacturing instructions, standard operating procedures, sampling instructions and plans, specifications, test methods, monitoring program, qualification and validation protocols and stability protocols
• Provide final signatory review for compliance on  all documents, including SOPs, SWIs, and Master Manufacturing Records to ensure compliance with the QMS, GMPs, regulatory and internal requirements such as company guidelines and approved procedures.
• Ensure that all quality issues arising during product development, routine manufacture, testing or distribution are appropriately identified and investigated. Ensure that all possible causes are identified and validated or invalidated by the evaluation of relevant data and/or sound, logical scientific argument.  Ensure that relevant CAPAs are defined, implemented and checked for effectiveness.
• Evaluate and approve/reject all completed CAPAs.

• Be the recognised expert in the Gennvax organisation on the requirements of GMPs and other relevant regulatory and industrial standards.
• Ensure that all facilities, equipment, utilities and IT hardware are qualified in line with company and regulatory requirements and that processes for utility production, product manufacture, disinfection, sterilisation, cleaning, analysis, IT systems etc are validated. With respect to these requirements :
  • Evaluate and approve/reject all Qualification and Validation Protocols for compliance
  • Evaluate and approve/reject all completed Qualification and Validation Protocols and associated data, for compliance
• Ensure that there is a robust training program in place on the site for all personnel. Training must include the understanding of the Gennvax QMS, Relevant GMPs and Regulatory Agency guidelines, the requirements of the Gennvax Documentation System and the resuirements of industrial organisations such as ICH, ISPE, PDA and ISO.

• Participate in the Gennvax Quality and Compliance Council so as to ensure that it effectively reviews quality and compliance reports and any serious issues.

• Ensure a constant state of inspection readiness and that all audit observations from the Gennvax self-inspection and supplier audit programmes, third parties and regulatory agencies are addressed quickly and completely to maintain readiness levels.

• With respect to the internal self-inspection programme, conduct these with the participation of other Gennvax functional areas and ensure a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to Senior Gennvax and Quality Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are effectively corrected.

• Participate in the Gennvax Change Control Management process and Review Committee to ensure that compliance issues are correctly evaluated and that any associated CAPAs are correctly defined to ensure compliance.

• Provide support to functional areas regarding the Change Control System by providing compliance assessments, work closure and follow up. Recommend documentation and supporting data to include in Change Control Requests to ensure that enough information is provided to the Change Control Review Committee so that informed decisions can be made.

• BSc/MSc from an accredited institution in Pharmaceutical technology, Biological Sciences, a Scientific or Technical discipliner or related field

• Ten plus (10+) years’ experience within a GMP biological product/vaccine and/or sterile pharmaceutical production environment.

• Six to ten (6-10) years experience in a GMP regulated environment.

• Minimum six plus (6+) years of experience must have been in a Quality Assurance/Quality Compliance role with experience in auditing.

The QMS and Compliance Manager will have the following core competencies :

• Self-Starter
• Energetic,
• Leadership Skills
• Collaboration and negotiating  skills
• Good communication skills
• Innovative and creative
• Ethical
• Attention to detail

Thorough understanding of Electronic Documentation Systems. Experience with SAP will be an advantage.

Technical knowledge of :

• EDA, WHO, EMA GMPs and regulatory guidelines
• The standards of recognised industrial oragnsiations such as ISPE, ICH, PDA, PICs, ISO and ISPE
• The manufacturing processes used for biological products, aseptic filling, packaging components and all operations necessary to produce high quality vaccines and sterile products.
• A thorough understanding of Biological production processes and procedures both upstream and downstream

Ability to:

• Evaluate and interpret data and formulate logical conclusions and recommendations.
• Excellent verbal and written communication skills.

Must be able to interface with personnel at all levels and guide functional teams to achieve results.

Key Production liaison for inspections by any global regulatory agency including EDA, WHO, and as relevant, EMA, USDA, JMAFF etc. Share expertise and represent the GennVax interests in Vaccine Production.

In depth understanding of the regulatory GMPs and guidelines that are relevant to the manufacture of vaccines. These will include WHO, EMA, EDA GMPs and guidelines and Industry standards such as PDA, ISPE, ISO, ICH as they are relevant to vaccine manufacture

The incumbent must be able to communicate clearly the cGMP requirements. Experience in audits of international regulatory agencies, particularly the EDA, WHO and EMA

Interact successfully within the highly energized production and regulatory environments, particularly site counterparts relating to manufacturing, testing, disposition, cold chain and distribution.

Continuous improvement process knowledge

Risk management

• Must be legally authorized and willing to work in Egypt without restriction.

• Must be willing to take a drug test and post-offer physical (if required)

• Must be 30 years of age or older