Quality Assurance (QA) Manager

About this role

Responsibilities

• The tasks listed below outline the scope of this position. The application of these tasks may vary, based on current business needs.
• Quality Assurance:
• 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.
• Quality Improvement:
• 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.
• Training and Development:
• 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.
• Data Protection:
• Assist DPO with Data Protection activities.
• Ensure adherence to applicable legislation, including GDPR.
• Information Security:
• 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.
• Minimum Qualification Requirements
• Training and at least 2 years’ experience in Good Clinical Practice.
• At least 5 years’ relevant QA experience, preferably within the life sciences sector.
• Other Information/Additional Requirements
• 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!
• Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
• As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.