Position: Senior QA GCLP/GLP Specialist, GCLP/GLP Testing Unit, IRBM
- IRBM is a drug discovery and development company with a track record of success in accelerating and executing the translation of novel discoveries into clinically relevant therapeutic modalities, including small molecules, peptides and monoclonal antibodies. IRBM is headquartered in Pomezia (Rome), Italy and provides several integrated pre-clinical laboratory services across the entire drug discovery process, ranging from target validation to clinical candidate molecule selection. The company collaborates with a number of Pharmaceutical companies, Biotechs as well as research institutes and non-profit foundations working in a range of disease indications. IRBM is committed to the discovery and development of novel therapeutic agents that can help fight and cure diseases.
- IRBM is looking for a Senior QA GLP/GCLP specialist to join our bioanalytical science unit at IRBM. The successful candidate will join a fast-paced team and will be responsible for all aspects of Quality Assurance: she/he will provide day-to-day support to all GLP/GCLP activities and will provide assurance to the company that all GLP studies and clinical sample assays are done in compliance with all applicable regulatory requirements and guidelines (OECD, ICH, FDA, EMA) and with company policies/ SOPs and current industry standards and practices. This individual is expected to maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GLP/GCLP Quality Assurance activities. The applicant will provide GCLP and GLP QA oversight and support to internal staff: she/he will be able to work effectively in a dynamic environment and will have demonstrated ability to interface with senior leaders and different levels of the organization. The successful candidate will be able to work under pressure and meet deadlines. A collaborative attitude and ability to multitask are essential for this position.
- Schedule, oversee and perform routine and non-routine quality assurance audits to include: vendors, process, facility, studies and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.
- Inspect study protocols, amendments and final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.
- Maintain copies of all approved study plans, master schedule and SOPs in use in the test facility and have access to an up-to-date copy of the master schedule.
- Develop and implement detailed audit plans and yearly GCLP/GLP audit schedules.
- Ensure the timely and effective follow up of all identified or assigned quality issues.
- Liaise and align with other applicable GXP (e.g. GMP) Quality Assurance teams.
- Schedule the quality assurance yearly program and deliver/schedules GCLP/GLP training for internal staff; assist with GCLP/GLP training of study site personnel as needed.
- Strong analytical and writing skills to identify issues, solve problems and document them appropriately.
- Excellent verbal and written communication skills with the ability to work well in teams and able to prioritize work, manage multiple projects while maintaining quality and meeting tight timelines.
- Outstanding organizational and record-keeping skills.
- Good computer skills.
- Excellent knowledge of English, spoken and written, is mandatory.
- Bachelor’s Degree in Scientific Discipline/ Life Sciences or related discipline; a combination of relevant education and applicable job experience may be considered.
- Minimum of 5+ years of pharmaceutical industry experience with at least 3 years of experience in GCLP/GLP Quality Assurance
- Solid understanding of GCP, GLP and ICH clinical requirements
- Previous participation in regulatory authority inspections is highly desired.