IRBM Group has a GMP-certified Contract Manufacturing Organization, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenovirus to support Phase I and Phase II clinical trials for vaccine and gene therapy applications.
Position: Quality Assurance Manager at ADVENT
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 adenovirus to support Phase I and Phase II clinical trials for vaccine and gene therapy applications. ADVENT is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) 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.
We are seeking an experienced and highly motivated individual to join the company as the Quality Assurance Manager to lead the cGMP 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 will play a critical leadership role within ADVENT and will the report directly to the Scientific Director. Proficiency in spoken and written English is a pre-requisite to apply for this position.
- 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 and the current GMPs are adopted.
- Prepare and approve standard operating procedures, according to the requirements of the regulations.
- Ensure that all necessary checks on semi-finished products 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.
- Be responsible of internal inspection and/or quality verification procedure, which allows the assessment of the effectiveness and applicability of the Quality Assurance 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.
- 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 direct small teams, including providing sound scientific direction, as well as building and motivating teams
- Proven ability to work in a team and to promote collaboration among team member.
- Master’s degree or higher in Science or related field.
- At least three years of experience in relevant position (Quality Assurance) in Biotech or Big-Pharma environment