R&D Compliance Leader (m/f/d)

Your Qualifications:

• Educational Background: PhD, MSc, or BSc in a scientific/medical discipline.
  
• Experience: Several years of experience in Clinical Research, Research, or an equivalent field.
  
• Regulatory Knowledge: A strong understanding of relevant Health Authority regulations, guidance, and the drug development process.
  
• Technical Skills: Ability to read and comprehend technical documentation, execute procedures, and understand system documentation.
  
• Organizational Skills: Strong organizational skills with high attention to detail.
  
• Computer Proficiency: Familiarity with industry-standard computerized system applications.
  
• Teamwork: Strong teamwork, communication, and interpersonal skills.
  
• Problem-Solving: Demonstrable problem-solving abilities.
  
• Process Improvement Mindset: A strong passion for quality and a mindset focused on continuous process improvement.
  
• Multi-tasking: Ability to manage multiple priorities effectively and work well under pressure and time constraints.
  
• Document Management Systems Experience: Experience with Veeva or other document/information management systems is desired.
  
• Independence: Ability to work independently with minimal supervision.

Your Tasks:

• Process Development and Optimization: Identify and establish processes that are 'fit for purpose' to support Pharmaceutical Diagnostics (PDx) R&D programs, focusing on clinical trials.
  
• Regulatory Compliance: Ensure business growth by simplifying processes and maintaining compliance with evolving regulatory environments. This includes creating new Standard Operating Procedures (SOPs) and rolling them out to relevant teams.
  
• Quality Enhancement: Identify and address compliance issues across R&D systems and processes to strengthen quality and maintain regulatory inspection readiness.
  
• SOP Management: Oversee and maintain the review cycle for R&D SOPs, working within the compliance team and collaborating cross-functionally with other departments as needed.
  
• Good Practices (GxP) Adherence: Ensure that all R&D activities adhere to relevant Good Practices (GxP) and Standard Operating Procedures (SOPs).
  
• Training Oversight: Support functional managers in training staff appropriately for their roles and ensure that training records are maintained as required.
  
• Compliance Reporting: Provide reporting metrics to disseminate compliance information across R&D teams.
  
• Audit Support: Contribute to the GxP audit schedule in collaboration with relevant R&D teams and Quality Assurance (QA). Lead and/or support GxP audits for both Contract Research Organizations (CROs) and internal departments.
  
• Regulatory Inspection Support: Assist with regulatory inspections and audits, including preparation, conduct, corrective/preventative action, and follow-up.
  
• Process Improvement: Proactively identify and implement process improvement initiatives within the R&D function.
  
• Risk Management: Collaborate with functional teams to identify and monitor risks, manage them within cost, quality, and time parameters, and develop contingency plans.
  
• GxP Expertise: Provide GxP expertise and advice to study and functional teams as needed.
  
• GxP Archivist: May act as a designated GxP Archivist or deputy as required.
  
• Document Management: Assist with the maintenance of the Document Management System (eTMF and Quality Vault), including upgrades, routine releases, access control, and training.

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