Quality Lead for Clinical Operations EMEA

Position: Quality Lead for Clinical Operations (freelance or payroll consultancy)

Overview: We are seeking a dynamic and experienced Quality Lead for Clinical Operations to join our team. This role is pivotal in ensuring the highest standards of quality and compliance in all our clinical trials and related research activities. The successful candidate will be at the forefront of driving quality initiatives and maintaining rigorous oversight across various clinical programs.

Key Responsibilities:

1. Quality Leadership:

   • Serve as the primary quality contact for a range of clinical studies including sponsored research, non-interventional studies, and early access programs.
   • Act as the quality liaison for Global Medical Affairs, ensuring alignment and compliance with quality standards.

2. Continuous Improvement:

   • Lead and support continuous improvement projects aimed at enhancing clinical quality.
   • Provide expert QA input into projects such as audit strategies, regulatory implementations, and procedural reviews.
   • Develop and drive risk-based internal audit plans to ensure proactive quality management.

3. Regulatory Compliance:

   • Stay abreast of new regulations and industry guidelines (e.g., ICH E6 R3) and assess their impact on clinical operations.
   • Ensure all clinical trials adhere to relevant regulations and guidelines, maintaining the highest standards of compliance.

4. Quality Oversight:

   • Implement and oversee quality metrics and trends, sharing insights and best practices for continuous improvement.
   • Coordinate the investigation of trial quality events, defining corrective and preventive actions as necessary.
   • Manage the Serious Breach Process and provide support for unblinded investigations.

Skills and Competencies:

• Extensive experience in Good Clinical Practices (GCP) and clinical quality management.
• Proven track record in quality oversight for various clinical research programs.
• Strong background in continuous improvement methodologies.
• In-depth understanding of clinical trial regulations and ICH guidelines.
• Excellent leadership skills with the ability to educate and motivate clinical teams on quality issues.
• Strong relationship-building capabilities with both internal and external stakeholders.
• Ability to thrive in a fast-paced, dynamic biotech environment with challenging deadlines.

Qualifications:

• A degree in Life Sciences or a related field.
• Fluent in English with excellent communication skills.

Why Join Us: This is an exclusive opportunity for individuals passionate about clinical quality and compliance. Whether you prefer to work as a freelance consultant or as part of our payroll team, you will play a crucial role in ensuring the success and integrity of our clinical operations. Join us and make a significant impact in a rapidly growing biotech company. Contact Gilles Carpentier (g.carpentier(at)realstaffing.com)