Hobson Prior are seeking a GxP QA Compliance Manager to join a biopharmaceutical organisation who are focused on the development and commercialisation of ground-breaking therapies for diseases.

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

Job Responsibilities:

• You will assist the internal and external audit program. Carry out Quality assessments / audits of Suppliers, Principle Investigators and GLP & GCP activities, follow-up on agreed upon corrective actions and train or approve lead auditors as needed.
• To confirm clinical and development programs are conducted in line with regulatory guidance.
• You will develop, observe and report on GxP Compliance QA metrics.
• To confirm post-marketing surveillance procedures and processes are conducted in line with national and international regulations and remain compliant with current applicable guidance.
• You will supply quality support to Clinical Operations teams.
• You will be guiding and supporting GxP trainings for employees to ensure knowledge on current guidance is maintained.
• To support and perform Data Integrity Reviews of non-clinical/clinical studies, clinical/commercial product manufacturing and regulatory submissions as needed.
• To handle of all non-clinical/clinical complaints, non-conformances, corrective actions, clinical temperature excursions and return material authorizations.
• Perform other duties as assigned.

Requirements:

• Educated at a bachelor's degree in Life Science.
• A minimum of 8 years' experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of US cGLPs and cGCPs. Also knowledge of cGMPs.
• Great understanding or experience of auditing to both GMP and GCP requirements.
• A minimum of 5 years of GxP and auditing experience.
• Excellent social, negotiation and communication skills.
• Certified Quality Auditor preferred.

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.