QA GCP Manager

Are you looking to drive groundbreaking quality assurance and make a real impact? Join our client and lead the way in advancing clinical quality assurance! 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). You will play a key role in ensuring compliance with applicable regulations and internal procedures, supporting audits and inspections, contributing to continuous improvement initiatives, and promoting a culture of quality across the business. This role provides an opportunity to take ownership of key QA processes and collaborate closely with stakeholders across the organization to drive high standards of quality and compliance.

• 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.

• 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.