Head of Clinical QA (f/m/d)

Responsibilities

• Strategic development and oversight of the compliance, quality, standards, and training for Affimed Clinical Development including Pharmacovigilance (PV) to ensure that quality requirements of Affimed and Health authority regulations (e.g., FDA, EMA) are being met
• Ensuring quality oversight of clinical programs
• Supporting the Clinical Development team and providing expert compliance advice
• Ensure GCP inspection readiness by assessing impact of new/updated GCP regulations, initiating and driving compliance initiatives and providing guidance on current practices and processes
• Qualification and QA oversight of clinical vendors
• Responsible for the planning, execution and effectiveness of the risk-based GCP audit program
• Planning, performing and reporting GCP, PV and clinical CSV Audits (System Audits, Trial Master File Audits, Clinical Trial Document Audits, Site Audits, Vendor Qualifications, Computerized Systems Audits, Audit Trail Audits, Database Audits, Document Audits); this includes a close follow-up with auditees to agree on CAPA-plans with the goal of risk mitigation
• Reviewing and analyzing audit and inspection results, deviations, non-compliance investigations and CAPA data to identify compliance trends
• Pro-active contribution to the development, the continuous improvement, and the maintenance of the overall Quality Management System
• Representing Quality in cross-functional program teams

Requirements

• Master Degree in life sciences or a healthcare related field
• 8+ years experience in clinical Quality
• Excellent knowledge of national and international regulations and guidelines applicable for the pharmaceutical industry especially with regard to GCP, GVP, Regulatory and Computerized Systems Validation
• Experience with development and oversight of clinical quality programs
• Significant experience conducting GC(L)P/PV audits (CROs/clinical vendors, investigator sites) as a lead auditor
• Experience working in cross-functional teams and in a matrix organization
• Strong team player supporting and guiding teams to ensure high quality standard
• Knowledge as a user of electronical systems e.g., document management systems
• Strong communication skills
• Good skills in MSOffice applications
• Fluent in English

Opportunity

• Multifaceted and responsible position, working on innovative projects in an international environment with strong team spirit
• Space for commitment and personal initiative with the possibility for personal and professional growth
• Attractive, performance-related compensation package and further benefits:
  • Employee financial participation in form of stock options
  • Attractive pension allowance from employer
  • Low-cost use of public transportation Job-/Deutschlandticket
  • Free parking spaces
  • Bike Leasing
• Flexible working time, possibility to partially work remotely (depending on function)
• Regular company events such as Culture Day, Summer Get-Together, participation in charity events

We are looking forward to receiving your application incl. motivation letter and salary expectations.

For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

November 2023