QA Manager

Hobson Prior have an exciting opportunity for a QA Manager to join a Biotech organisation who focuses on developing innovative immunotherapies for cancer that stimulate the body's own immune system.

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

Key Responsibilities:

• Review processes and systems on an ongoing basis to determine where improvements can be made and ensure activities are conducted in compliance with the requirements of GMP and GCP.
• Schedule and conduct GMP and GCP external audits e.g. CMOs, Investigator Site Audits and other types of vendor/supplier audits.
• Track QMS activities, including CAPAs and deviations, and the implementation of corrective actions.
• Provide advice and support to functional operational teams.
• Provide input into the SOPs, policies, work instructions and other controlled documents.
• Assist with the preparation and facilitation of regulatory agency inspections e.g. MHRA and FDA inspections.
• Update all staff with changes in regulations and guidelines.
• Prepare periodic reports to Head of Quality and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goals.

Requirements:

• Ability to build strong relationships and work collaboratively both with internal team members, vendors and other external third-parties.
• Scientific degree.
• At least 5 years GCP and GMP experience in the pharmaceutical industry.
• At least 3 years QA auditing experience.
• Excellent knowledge of relevant regulatory requirements with working knowledge of GCP and current GMP requirements, ISO 9001 or similar regulations and standards (considered).
• Excellent interpersonal, communication, and problem solving skills.
• Strong computer skills.
• Flexible in reacting to changing priorities in a dynamic business environment.
• Ability to travel as required.

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.