Director, Global Development Quality Assurance (GDQA) - Remote

Proclinical is seeking a dedicated individual for a Director of Quality Assurance position. This role is integral to our mission of developing solutions for some of the most crucial scientific challenges of our age. The successful candidate will be a key player in our team, driving risk-based approaches to complex business problems and providing expert input to various functional teams. This role is an opportunity to contribute to the creation of hope for a healthy future in many people's lives.

Responsibilities:

• Drive risk-based approach to solve complex business problems.
• Provide expert input to functional teams in areas such as Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs and Companion Diagnostics.
• Drive change initiatives in area of expertise in partnership with functional groups.
• Contribute to organisational quality and compliance reporting requirements.
• Prepare and deliver clear, informative and timely reports for service management.
• Lead and support the development of management reporting on quality key performance indicators.
• Establish and maintain regular structured interactions with key stakeholders.
• Lead and collaborate with management and operational teams to adjust processes, practices as needed to meet business needs.
• Work with management teams to set quality targets and report against those targets.
• Collaborate with teams to identify areas for improvement and implement quality assurance measures.
• Ensure a proactive risk-based strategy is established and implemented for inspection readiness.
• Collaborate with key internal and external stakeholders and service providers to develop effective business partner relationships.
• Provide guidance on health authority regulations expertise, such as FDA, EMA, MHRA.
• Provide strategic leadership to the team for development of programs and strategies.
• Engage with the business to identify improvement opportunities.
• Liaise with other managers and staff and provide training, tools and techniques to enable others to achieve quality standard.

Key Skills and Requirements:

• Significant understanding within GxP operational and quality roles.
• Operational experience in at least one of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs or Companion Diagnostics.
• Strong and proven team leadership skills
• Deep knowledge in drug development and development of medical devices is a plus.
• Strong knowledge of Clinical Development and Research operations and regulatory landscape.
• Deep knowledge of GCP, GLP, GPVP, GCP for Labs and a general understanding of GMP.
• Expert in process development, industry standard problem-solving approaches, in alignment with Lean and Lean Six Sigma principles.
• Knowledge in worldwide regulations and guidelines (including ICH, FDA, EMA, MHRA, ISO) related to clinical development.
• Knowledge in Inspection Readiness, Inspection Preparation and Inspection Management.
• Experience of driving Continuous Improvement and Quality Management Systems in a high complexity environment.
• Excellent written and oral communication skills and relevant IT skills.
• Ability to work in a matrix management structure, embedded in a dynamic R&D environment.
• Ability to work within a team, providing support and encouraging development.
• Fluent in English and other languages is an advantage.

Interested or know someone who might be? Reach out to ­­­­Josh Godden using the following:

✉️ j.godden@proclinical.com

📞 0203 854 0101 (5324)

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.

Proclinical is acting as an Employment Agency in relation to this vacancy.