R&D Quality Manager & Senior Auditor (m/f/d)

R&D Quality Manager / Senior Auditor (m/f/d)

For a pharmaceutical project, we are looking for an R&D Quality Manager / Senior Auditor. Start: ASAP. Duration: 6 months, with the option of permanent employment.

Location: Frankfurt am Main, with 2‑3 days of remote work per week.

This role is responsible for quality oversight and support for clinical development projects and the R&D Quality Management System. It includes an independent review of the planning, conduct, reporting and documentation of clinical activities and the computer systems used, on the basis of the relevant medical device and pharmaceutical legislation, regulations, standards and guidelines.

Audit Programs

• Planning and performance of various clinical medical devices and medicinal products project audits (e.g. investigator site audits, process audits, TMF audits, CSP/CSR audits) against GxP and local regulatory requirements.
• Creating audit plans for studies based on risk assessments/analyses.
• Planning and performance of internal process and vendor audits.

Quality Issue Management

• Lead the evaluation and management of clinical site‑specific escalations related to persistent or serious misconduct.

Quality Management System

• Collaboration in further development and maintenance of the R&D quality management system (document management, CAPA, deviation and SOP system).
• Assistance in development of company standard operating procedures.
• Collaboration on quality metrics for reporting to leadership.

Quality Consultation & Project‑Specific Support

• QA business partner for the clinical operations team; support the CAPAs management of relevant ClinOps sub‑divisions.
• Provide independent consultation focused on clinical activities in collaboration with project teams.
• Provide consultation for quality‑related and GCP‑related inquiries for clinical activities in R&D.
• Support supplier qualification processes relevant for clinical development.
• Plan and perform audits of clinical vendors (CROs, warehouses for clinical supplies, clinical laboratories, couriers, archiving services) against GxP and local regulatory requirements.

Training

• Contribution to training for selected functional groups on Good Clinical Practice, Good Clinical Laboratory Practice, Good Pharmacovigilance Practice (pre‑marketing), and clinical trials regulations.

Regulatory Authority Inspections

• Host local and international notified body and authorities' inspections / external audits.
• CAPA management of regulatory authority inspections / external audits.
• Support inspection readiness and regulatory compliance status at R&D.

Technical & Functional Skills

• Fluent English (written and verbal) mandatory.
• Comprehensive knowledge of regulations and standards for conducting clinical trials in medical devices or medicinal products.
• Comprehensive knowledge of audit execution in the GCP area (ISO 14155 for medical devices, ICH‑GCP E6 for pharmaceuticals).
• Knowledge of Microsoft Office Suite (Excel, Word, PowerPoint, WebEx/Teams, SharePoint).
• Management and facilitation of audits/inspections (including GCP audits of any type, sponsor inspections).

Minimum Qualifications

• Bachelor's degree in natural science, pharmacy, or medicine.
• 10 years of professional experience in clinical quality assurance oversight and/or management.
• 5 years of professional experience as a QA auditor and leadership in QA management in the pharmaceutical or medical device industry.

Preferred Qualifications

• Master's degree in natural science, pharmacy, or medicine.
• Prior experience developing risk‑based quality management programs across clinical development.
• Experience working and communicating within cross‑functional teams.
• Knowledge of overall clinical trial management process, including protocols and other trial plans.
• Critical thinking and analytical skills for understanding and analyzing complex data and providing insights into risk reports, trends, and outliers.