Hobson Prior are currently working with a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. Our client is seeking a QA Operations Lead to join them on a contract basis in Switzerland.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• To work with Senior Quality manager in providing Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing.
• Develop and track KPIs for internal and external performance in relation to batch release activities.
• Co-operate with CMO Quality to ensure a robust batch release process in accordance with agreed processes and defined timelines.
• You will partner with stakeholders across different operational functions and participate in projects in border to improve processes.
• Oversee batch disposition status for European patients and ensuring availability and completeness of documentation required for final drug product release (QP release).
• Review and follow up of CMO deviation investigations, CAPA. Independent review of controlled documents (Master records, protocols, reports, SOPs).
• Closing and remediation of detected gaps in collaboration with CMO.
• Support in review and approval of internal investigations and CAPA affecting the CMO.
• Support and act in quality related improvement projects in collaboration with affected CMO functions.
• May occasionally be responsible for batch record review of intermediate product (Make 1) and system release.

Key Skills:

• Robust organizational skills, including ability to follow assignments through to completion.
• Ability to work self-sufficiently and reliable with regards to quality and timeframes.
• Very good verbal and written communication skills.
• Capable of working in cross functional teams.

Requirements:

• Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas or comparable education with experience in GMP industry.
• First experience in EU GMP regulated industry within in quality assurance, quality control, or manufacturing.
• Knowledge of relevant regulations and guidance.
• Fluent in English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.