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