Hobson Prior are currently recruiting for an exciting opportunity for a Manager (Regulatory Compliance) to join a thriving research-based pharmaceutical company on a contract basis in Cambridge.

Job Responsibilities:

• Manage and lead routine and complex PV audits including internal processes, vendor and affiliate audits.
• Write audit execution plans.
• Writing audit reports.
• Communicating audit findings.
• Evaluate internal and vendor reported non-compliance and approve CAPA plans.
• Conduct risk assessments.
• Review responses to audit reports to determine acceptability of proposed CAPAs.
• Perform CAPA verification through review of objective evidence.
• Write CAPA effectiveness methodology.
• Complete CAPA effectiveness checks.
• Undertake reviews of internal Procedural Documents.

Requirements:

• A minimum of 8+ years of relevant experience (relevant work experience consists of working as a pharmacovigilance auditor and/or in a pharmaceutical quality assurance environment).
• Lifesciences degree.
• Must have an in-depth knowledge of global pharmacovigilance requirements.
• Experience of using TrackWise is advantageous.
• Ability to travel (nationally and internationally) to conduct on-site audits (minimum of one audit trip abroad each month).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.