R & D QA Lead

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process? Our Client, a global leading Healthcare company, is looking for a QA Lead.

Tasks

• Plan and carry out audits for internal teams, vendors, partners, and clinical trial sites, and manage the audit calendar.
• Coordinate with external auditors, helping schedule their work and making sure all documents are properly handled.
• Write audit reports, track any issues found, and ensure they are resolved on time.
• Keep audit systems updated to meet GxP standards, regulatory rules, and company policies.
• Review audit results to spot risks, suggest improvements, and raise concerns when needed.
• Support regulatory inspections, including getting ready, helping during the inspection, and managing follow-up actions.
• Offer guidance on GxP compliance to internal teams and during meetings.
• Make sure third-party partners follow quality agreements, and follow up on any concerns about product quality, safety, or effectiveness.
• Create and update procedures (SOPs) and help with training and documentation related to GxP.
• Work closely with other departments to stay compliant, improve processes, and support company goals.

Profile

• Solid experience in auditing or quality assurance (QA) in the pharmaceutical industry, especially in Good Clinical Practice (GCP).
• Hands-on experience with CAPAs, handling audit findings, and managing deviations.
• Holds a science degree (e.g., Pharmacy, Chemistry, Biology, Engineering) or has equivalent experience with an auditing certification.
• Deep experience in GCP or GVP auditing or QA roles in pharma.
• Strong knowledge of global GxP regulations, including UK, EU, FDA, PIC/S, WHO, and ICH guidelines.
• Good understanding of the EU Clinical Trial Directive (CTD), the drug development process, and contracts with CROs and vendors.
• Skilled in auditing methods, reporting deviations, finding root causes, and managing CAPAs.
• Able to review technical details, identify compliance risks, and apply GxP rules effectively.
• Communicates clearly with all levels of staff and can lead audits independently while managing stakeholders.
• Well-organized, able to handle multiple tasks, and works well both independently and in teams.
• Proficient in writing technical reports, audit documentation, and compliance summaries.
• Comfortable using Microsoft Office tools (Word, Excel, PowerPoint, Outlook) and other project software.

Contact

Please contact me on ammar.nabi@phaidoninternational.com or please call me on +49 30 726211428 for further information.