Reporting into the Quality Assurance Director, this role will provide objective compliance advice and play a key role in the continuous development, oversight, maintenance and strengthening of the company Quality Management System (QMS) in the area of Good Clinical Practice (GCP). Working closely with the site QA Manager (GMP) and Clinical Project Director to oversee GCP activities

The role will provide GCP oversight and support to Ixaka clinical staff working on Ixaka sponsored projects.

This is an in-company position that can be based in London or in Seville or remotely with 30% travelling time.

Responsibilities

• Review, develop and implement robust GCP SOPs as well as other quality documents whilst ensuring training of these SOPs are performed.
• Participate in in the development of Quality Risk Management Activities on Ixaka projects
• Reassess quality risk throughout projects and promote continuous improvement of the GCP system
• Partner with the Ixaka clinical Operational team and respective CROs to monitor site level quality risks
• Provide day to day quality and compliance support to the Team including issue management (investigation/actions), audit response, Regulatory audit/inspection preparation and coordination e.g FDA, MHRA, proactive quality management, CAPA management and oversight, protocol design, participate to protocol deviation review meetings, audit/protocol deviation/issue trending, standard procedures drafting and reviewing and vendor management as needed
• Perform Vendor audits as needed
• Ensuring the organisation's audit and regulatory inspection readiness at all times
• Ongoing maintenance and review of the organisations quality systems making improvements and adjustments as required to ensure compliance at all times
• Participate in definition of GCP KPI and provide Quality Metrics Review for management review
• Prepare Ixaka GCP QMS for any regulatory and internal QMS inspection
• Perform and/or participate in Sponsor audits at CROs and Clinical sites if needed
• Work with the GMP QA to develop and implement annual audit strategies and schedule, conduct and track audits in accordance with approved audit plans.

Requirements:

• Degree in Science or Life Science
• Pharmaceutical or allied industry experience (3-5 years) including direct quality assurance and regulatory compliance
• Current working knowledge of GCP/ICH, EMA and FDA regulations and guidelines. Knowledge of Good Clinical Laboratory Practices (GCLP) would be a plus
• Experience in hosting and supporting regulatory audits
• Strong analytical skills
• Experience working with CTIMPs, Non-CTIMPs, ATMPs and/or biologicals sterile products
• Strong written and verbal communication skills English. Spanish language would be an advantage but not essential
• Ability to work with others as well as independently
• Excellent organizational and time management skills
• Able to communicate well at all levels in the organization
• Strong capacity for problem solving