Quality Assurance Manager

We have an exciting opportunity for a Quality Assurance Manager to join Veramed on a permanent basis in the UK. This role offers flexible home and/or office working, best-in-class training, and a competitive total reward package.

The primary purpose of this role is to support the Director, Quality & Compliance in the delivery of Quality Assurance activities and the ongoing oversight, maintenance and improvement of the Quality Management System. 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. The role offers scope to take ownership of key QA processes and to work closely with stakeholders across the organisation to drive high standards of quality and compliance.

The tasks listed below outline the scope of this position. The application of these tasks may vary, based on current business needs.

• Management of the Quality Management System.
• 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 QA approval of SOPs and other controlled documents.
• Effectively monitor compliance to processes.
• Provide input for and maintain oversight of CAPAs and Quality Issues.
• Generate Quality metrics reports to provide updates to the Management Team on quality related issues and initiatives.
• Ensure company-wide compliance to EU and UK clinical trial legislation, ICH GCP and other applicable legislation.
• QA review of Computerised Systems Validation (CSV) projects.
• Perform risk assessments where required.

• Empowered to promote good practice by challenging standards within the workplace and by suggesting areas for improvement.
• Inspire and drive company to achieve and maintain quality values.
• Review of lesson learned meetings, customer concerns, issues and CAPAs for quality-related items and responsibility for coordinating any resulting training or process updates.

• Development, coordination and delivery of training materials related to quality, including GCP.
• Perform work in full compliance with applicable legislation, regulations, company policies, procedures and training.

• Assist 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/or where required, draft new SOPs/POLs on this topic.
• Conduct IS audits – internal and vendors.
• Support Information Security Assessments (of Veramed).
• Conduct Information Security Assessments of potential vendors.
• Assist with management of potential and actual data breaches, in conjunction with ISSC, ELT and DPO.

• Training and at least 2 years’ experience in Good Clinical Practice.
• At least 5 years’ relevant QA experience, preferably within the life sciences sector.

• Expert knowledge of UK, EU and US clinical trial legislation.
• Able to communicate effectively and influence across and within the organization.
• Excellent written and verbal communication skills.
• Excellent interpersonal and negotiation skills.

If you’re passionate about quality and want to make a meaningful contribution within a people-focused organisation, we’d love to hear from you!

At Veramed, people are at the heart of everything we do. We are proud to be an equal opportunities employer and are committed to creating an inclusive working environment based on integrity, honesty and respect. All qualified applicants will receive equal consideration for employment regardless of race, nationality, religion, gender identity or expression, sexual orientation, disability or any other protected characteristic.