Description

ITF Therapeutics is seeking a temporary contractor for a Manager, Quality Systems position on our Quality team. The role owns the training, document control, and records management processes within the Quality Management System. ITF Therapeutics is dedicated to providing new therapeutic options for individuals with rare diseases. It is the US division of Italfarmaco S.p.A., a private global pharmaceutical company founded in 1938 in Milan, Italy. Italfarmaco has successfully developed numerous innovative therapeutic products approved for patients worldwide.

Role Responsibilities:

• Manage operational needs for the training program, including new hire onboarding, training assignment, facilitating GxP job descriptions and CVs, annual training reviews, and offboarding.
• Oversee the training matrix and annual training plan
• Manage the operational requirements for Document Control, such as draft-to-effective/approval workflows for controlled documents, periodic reviews, document revisions, and obsolescence.
• Oversee records management processes, including archiving and retention timelines.
• Develop and implement processes, training, and infrastructure to ensure compliance with good documentation practices, data integrity, signatures, and electronic signatures. Provide organizational training and support.
• Support computer system validation efforts for updating the eDMS and eLMS.
• Regularly generate performance metrics to monitor system performance and effectiveness, providing feedback to the Quality team for action and improvement.
• Identify and mitigate risks or weaknesses within the system to promote continuous improvement.
• Ensure that process elements comply with regulatory requirements, health authority expectations, and current best practices.
• Serve as SME on training, document management, and records management processes during audits and inspections.
• Complete assigned training on time.
• Perform other duties as assigned.

Requirements

• 6+ years of QA experience within biotechnology, pharmaceutical or device firms
• Experience within training, document control, and records management processes and oversight
• Strong knowledge of cGMP
• Experience in developing computer based and instructor led trainings.
• Experience learning new eDMS, and eLMS systems, adapting processes to the system, and supporting end users
• Proactive in identifying opportunities with a robust solution-minded approach and flexibility to emerging challenges.
• The ability to comprehend regulations and guidance documents, apply critical thinking skills to evaluate requirements, and effectively communicate written and oral findings.