Job Position: Production associate, Downstream unit. IRBM Group has a GMP-certified Contract Development and Manufacturing…
Position: Quality Assurance Manager at ADVENT
ADVENT is a GMP-certified Contract Development and Manufacturing Organization, located in Pomezia (Rome) within the IRBM campus and it is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the FDA and EMA regulatory guidelines. Advent is fully dedicated to develop and produce clinical lots of recombinant adenoviruses supporting clinical trials for vaccine and gene therapy applications. Over the years, ADVENT has built an outstanding track record in the successful production of clinical lots for cancer therapy and infectious diseases prevention, including the production of a candidate vaccine for Ebola and Covid-19, which is currently in phase III trials.
Advent is committed to the highest GMP quality standard and is currently expanding both in terms of infrastructure and personnel.
ADVENT is currently seeking an experienced and highly motivated Quality Assurance Manager to lead our Quality Assurance Unit, supporting the development, manufacture, and testing of adenoviral vectors for clinical trials. The successful candidate will ensure that ADVENT’s development, manufacturing and distribution activities are compliant with the latest GMP regulatory standards. He/she will be responsible for identifying and ensuring that compliance risks are appropriately identified and mitigated. This individual will also be responsible for the implementation of electronic systems, including but not limited to electronic Document Management System and electronic Records Archive System. In this leadership position, she/he is expected to provide strategic input, identify gaps and issues and proactively propose and implement solutions. The candidate will have people management responsibilities and will report directly to the ADVENT Director.
- Ensure the company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards. Verify that the production and quality control operations are clearly specified and the established GMPs are adopted.
- Design, implement, and maintain QA and GMP compliance programs and infrastructure, including SOP development/maintenance, document control/change control processes, internal/external audits, deviation review and tracking, investigations and corrective/preventive actions.
- Responsible of internal/external inspections, audits and/or quality verification procedures, which allow the assessment of the effectiveness and applicability of the Quality Assurance system. Manage follow-up on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
- Liaise with Information Technology (IT) to design, implement and maintain functional requirements for all GMP Quality Systems; Lead the transition to a fully integrated electronic system in accordance with data integrity principles.
- Pro-actively provide input to ensure that the most appropriate agreements are made for the manufacture, supply, use of raw materials and packaging materials.
- Provide leadership, mentorship and coaching as a member of the ADVENT leadership team.
- Results-driven personality with high level of enthusiasm, energy and confidence.
- Excellent communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise verbal communication skills).
- Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to details.
- Strong interpersonal skills and the ability to assist personnel in a fast-paced environment and the ability to proactively resolve issues.
- Proficiency in spoken and written both Italian and English is mandatory to apply for this position.
- Master’s degree in a life science is required, PhD in a scientific or management discipline would be considered a plus.
- Minimum 5-7 years directly related experience supporting drug development in a quality or a similar function.
- Deep and proven understanding of GMP, GCP and ICH clinical requirements for Biologics and/or Advanced Therapy Medicinal Products is required. Previous experience with the GMP manufacturing of Adenoviral vectors would be considered a plus.
- Deep understanding of and familiarity with implementing and using electronic solutions for GMP and Quality Assurance system.