Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is looking for a Compliance Manager to join them on a permanent basis where you will be required to be home-based.

Job Responsibilities:

• To help build a culture of Inspection readiness and sustainable compliance initiatives.
• Works closely with the Line Manager and the wider Operations team in maintaining the OKRs objectives and Inspection Readiness culture into the organisation.
• Supports the Quality Management System within the Operation team from a Compliance perspective.
• Drafts, reviews and maintain Policies, SOPs, Quality Events (Deviations, CAPAs, Supplier Corrective Actions) and manages them within the (electronic) Quality Management System.
• Delivers the 'Super User" role for MasterControl (eQMS) for the Operational team.
• Provide support within the existing paper based QMS in terms of update, maintenance, drafting, QC of procedural documents and any other documents as required.
• Performs Sponsor Oversight Visits for vendors and investigator sites on behalf of the organisation as a method of quality control check.
• TMF Lead for the organisation's Trial Master File/s.
• CRO TMF Focal Person for Sponsor Trial Master Files (that reside with the CROs).
• Perform QC review of the Trial master file on a periodic basis.
• Support the wider Operational team in helping them with compliance issues by providing recommendations considering regulations, guidance documents and industrial practices.
• Checks / maintains the compliance and quality of the documents, in relation to Standards, Guidance and the organisation's procedures and expectations.
• Supports in any other tasks as deemed appropriate by the Line Manager.

Key Skills:

• Strong communication skills, liaising with colleagues and system providers.
• Proven ability to change, prioritise accordingly and maintain strong organisational skills.
• A willingness to be flexible, performing responsibilities not identified in this role specification, and assuming responsibilities as our needs change.
• Must have the ability to work independently and also a good team player.
• Proven ability to provide practical and pragmatic solutions with speed and efficiency.

Requirements:

• A degree in life sciences or related field is preferable.
• At least 5 years' experience within Clinical Operations and/or Quality Assurance.
• Knowledge of Quality Management System maintenance, CAPAs and Deviations, handling Protocol Deviations and Sponsor Oversight Visits (Investigator site audits), is preferable.
• Mandatory experience in a biotech/pharma industry; preferred to have experience in electronic QMS (MasterControl[1] preferred) and eTMFs such as Veeva Vault.
• Previous experience of writing standard operating procedures and drafting deviations and CAPAs is essential.
• Good Document Administration / IT (MS Office) skill-set.
• Demonstrated commitment to quality (Big Picture Approach).

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.