Hobson Prior has partnered with a clinical-stage biopharma organisation who are committed to delivering life-changing treatments to transform the lives of patients living with cancer. This position will be involved in establishing, developing and managing systems to ensure Quality governance of all internal and outsourced activities in support of regulatory filings and clinical trial conduct.

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

Job Responsibilities:

• Development and execution of strategic QA activities in line with corporate goals.
• To provide guidance in application of the QMS to all stakeholders.
• Development and management of QMS overseeing all outsourced activities (including CRO selection and approval, contract auditor management, non-compliance assessment and performance monitoring).
• Assessment and guidance in quality events in relation to clinical development services provided by CRO.
• Development and management of QMS for internal activities impacting regulated activities.
• Accountable to maintain ongoing understanding of regulatory expectations and apply pragmatically to company processes.

Key Skills:

• You are pragmatic, risk based, solution driven focus.
• A "can do" attitude, essential to a fast-paced biotech environment.
• Ability to work under pressure and prioritise.
• You are skilled in networking both internally and externally.

Requirements:

• You are educated in bachelor's degree ideally in science related discipline.
• Excellent understanding of USA/EU/ICH GCP requirements.
• Experience in development and management of eQMS /DMS systems.
• Proven QA experience within a biotech/bio-pharmaceutical company/CRO developing a pipeline of molecules through early to mid-phase clinical trials and beyond.
• Wide-ranging experience of operational clinical QA and its practical application in early/mid phase trials.
• Proven experience of managing CRO performance though quality governance, oversight and use of external consultants/auditors.
• Proven experience of application of risk management tools to drive resolution and mitigation.
• Experience in development of risk-based data integrity processes suitable for small biotech environment.

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.