QA Manager job in Cambridge, England

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Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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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