Qa Gcp Manager Job at Proclinical (City of London)

Job Description

Proclinical is looking for a Quality Assurance Manager to join a dynamic organization on a permanent basis in the UK. This role offers flexible home and/or office working, industry leading training, and a competitive total reward package. The primary purpose of this role is to support the Director of Quality & Compliance in delivering Quality Assurance activities and overseeing, maintaining, and improving the Quality Management System (QMS).

Job Responsibility

Manage the Quality Management System (QMS)
Contribute to the generation and management of the internal audit schedule
Independently conduct and report audits in accordance with the internal audit schedule
Conduct vendor audits as instructed
Lead, manage, and coordinate client audits and regulatory inspections
Respond to and follow up on audit reports and vendor questionnaires
Review and provide QA approval of SOPs and other controlled documents
Effectively monitor compliance with processes
Provide input for and maintain oversight of CAPAs and quality issues
Generate quality metrics reports to update the management team on quality-related issues and initiatives
Ensure company-wide compliance with EU and UK clinical trial legislation, ICH GCP, and other applicable regulations
Perform QA reviews of Computerized Systems Validation (CSV) projects
Conduct risk assessments where required
Promote good practices by challenging existing standards and suggesting areas for improvement
Inspire and drive the organization to achieve and maintain quality values
Review lessons learned from meetings, customer concerns, issues, and CAPAs for quality-related items, and coordinate any resulting training or process updates
Develop, coordinate, and deliver training materials related to quality, including GCP
Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
Assist the Data Protection Officer (DPO) with data protection activities
Ensure adherence to applicable legislation, including GDPR
Assist in hosting ISO27001 accreditation and subsequent surveillance audits
Review SOPs for information security compliance and draft new SOPs/policies as required
Conduct internal and vendor information security audits
Support information security assessments of the organization
Conduct information security assessments of potential vendors
Assist with managing potential and actual data breaches in conjunction with relevant teams

Requirements

Training and proven years of working experience in Good Clinical Practice (GCP)
Professional working years of relevant QA experience, preferably within the life sciences sector
Expert knowledge of UK, EU, and US clinical trial legislation
Strong ability to communicate effectively and influence across and within the organization
Excellent written and verbal communication skills
Exceptional interpersonal and negotiation skills

What we offer

Flexible home and/or office working
Industry leading training
Competitive total reward package

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