QA Manager

Proclinical are in search of a dynamic and talented QA Manager, with great QA experience. You will be responsible for GCP activities, ensuring that they are compliant within the appropriate regulations.

Job Responsibilities

• Establish, develop and manage systems to ensure Quality governance of all internal and outsourced activities in support of regulatory filings and clinical trial conduct. It will also include:
• Development and execution of strategic QA activities in line with corporate goals.
• 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).
• Experience in development and management of eQMS /DMS systems.
• 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.
• Maintain ongoing understanding of regulatory expectations and apply pragmatically to company processes.

Skills and Requirements

• Educated in Bachelor's degree ideally in science related discipline
• Ability to lead and influence diverse teams across a complex multidisciplinary supply chain and clinical network.
• Agility as evidenced by flexibility, adaptability, collaboration, initiative.
• Skilled in networking both internally and externally.
• Proven QA experience within a biotech/bio-pharmaceutical company/CRO developing a pipeline of molecules through early to mid-phase clinical trials and beyond.
• Excellent understanding of USA/EU/ICH GCP requirements pertinent to F-star products.
• Extensive 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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