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Quality Assurance Manager at ADVENT – Ref. 168 B

Position: Quality Assurance Manager at ADVENT – Ref. 168 B

ADVENT is a GMP-certified Contract Manufacturing Organization, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenoviruses to support clinical trials for vaccine and gene therapy applications. ADVENT is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) as well as to perform QC tests of commercial vaccines and is compliant with the regulatory guidelines of both FDA and EMA. Over the years, ADVENT has built an outstanding track record in the successful production of clinical lots and is committed to the highest GMP quality standard. A key partnership is with AstraZeneca for the manufacture of clinical trial supplies and release testing of commercial COVID-19 vaccine, now authorized by the MHRA and EMA.

We are seeking an experienced and highly motivated individual to join the company as the Quality Assurance Manager to lead the Quality Assurance functions supporting through all phases of clinical product release. The successful candidate will be responsible for applying GMP controls and monitoring quality expectations for product development in a phase appropriate manner. She/He/Non-binary will play a critical leadership role within ADVENT and will report directly to the Head of Quality and in dot line to the Scientific Director & Qualified Person.

Key responsibilities:

  • Ensure that Biological Investigational Medicinal Products manufactured at Advent are designed and developed according to the current GMPs.
  • Verify that the production and quality control operations are clearly specified in a written form and the current GMPs are adopted.
  • Review and approve standard operating procedures, according to the requirements of the regulations.
  • Ensure that the product is correctly processed and checked according to the defined procedures.
  • Ensure that all necessary checks on starting materials, semi-finished products and other in-process controls are carried out during the production process and the validations.
  • Warrant that the Investigational Medicinal Products are not supplied to third parties, before a Qualified Person has certified that each production lot has been produced and controlled in accordance with the provisions of the GMP authorization and any other regulation relevant to production, to the control and approval of investigational medicines.
  • Ensure that satisfactory arrangements exist to ensure, as far as possible, that the products are stored and handled so that quality is maintained throughout their shelf life.
  • Ensure that there is a procedure for internal inspection and/or quality verification, which allows the assessment of the effectiveness and applicability of the Quality Management System.
  • Ensure that all development and manufacturing operations are fully documented and that the history of each production batch can be traced.
  • Pro-actively provide input to ensure that the most appropriate agreements are made for the manufacture, supply, use of raw materials and packaging materials.
  • Evaluate and manage Deviations, OOS and change controls.
  • Manage complaints handling and provide customers with appropriate investigation reports.
  • Review/Approval of protocols and reports for validation of equipment, facilities, utilities, processes, cleaning procedure, etc.)
  • Ensure controlled distribution and archiving of documents, approval of all quality-related documents.
  • Provide training and guidance for new staff and periodic/corrective training to all personnel.
  • Ensure Quality Product Review of the manufactured products.

Leadership competencies/skills:

  • Results-driven personality with high level of enthusiasm, energy and confidence.
  • Excellent analytical, communication, organizational and presentation skills are essential.
  • Proven leadership skills required to supervise teams, including providing sound direction, as well as building and motivating teams.
  • Proven ability to work in cross-functional teams and to promote collaboration among team members.

Requirements:

  • Master’s degree or higher in Science or related field.
  • Proficiency in spoken and written English.
  • At least three years of experience in relevant position (Quality Assurance) in Biotech or Big-Pharma environment.
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