QA Manager
- Employer
- Proclinical Staffing
- Location
- Cambridgeshire, England, Cambridge
- Salary
- Negotiable
- Start date
- 10 Feb 2021
- Closing date
- 24 Feb 2021
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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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Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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