R&D Quality Lead - Site Redmond, travelling to Seattle, WA

Role Summary

R&D Quality Lead responsible for contributing to the development, implementation, and maintenance of Quality Management systems and activities for Just-Evotec Biologics (JEB) Product and Process Development. Ensures quality and regulatory requirements are met for GCP, GLP, GVP and site/vendor compliance with applicable GxP regulations; supports inspection readiness and risk mitigation in clinical trials.

Responsibilities

• Provide quality oversight for data generated by the product and process development (P&PD) function
• Partner with senior members of clinical and medical staff to develop plans for quality oversight of GCP and GVP activities
• Maintain strong relationships with multiple internal and external team members and cross functional groups
• Provide quality oversight to GCP/GLP/GVP vendors through vendor qualification and other appropriate quality oversight mechanisms as applicable
• Provide leadership for study team inspection readiness, and support GCP/GLP/GVP regulatory sponsor inspections globally
• Oversee/support the development of SOPs for internal GCP/GLP/GVP activities as well as monitoring and ensuring continuous improvement of these procedures/processes
• Input into planning of audits of systems and processes needed to support regulatory submissions
• Continuously assess compliance status of clinical programs/studies
• Perform quality document review and approval as required
• Assist with or provide GCP/GLP/GVP training for JEB employees as appropriate
• Oversee investigations of GCP/GLP/GVP related quality issues, deviations, and root cause investigations. Collaborate with GCP/GLP/GVP functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs
• Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate
• Provide input to and support for Quality Management Review
• Travel to JEB local and international sites as required

Qualifications

• Bachelor's degree Life/Health Sciences and/or master's degree; a plus
• Minimum 7 years of leadership experience
• 12 plus years' experience in clinical quality assurance or clinical operations background, in a regulated biotechnology, pharmaceutical or diagnostics industry environment
• Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GCP required. GLP and GVP preferred
• Knowledge of QMS and CAPA related processes and systems is required
• Ability to work across GCP/GLP/GVP functional areas and foster a collaborative culture of quality within the organization
• Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors, clinical sites and vendors is strongly desired
• Must have applied experience in quality assurance auditing and applicable regulations

Skills

• Quality Oversight
• GCP/GLP/GVP Knowledge
• Regulatory Submissions and Inspection Readiness
• CAPA and Risk Management
• Vendor Quality Oversight
• Cross-functional Collaboration

Education

• Bachelor's degree in Life/Health Sciences; Master's preferred

Additional Requirements

• Travel to JEB local and international sites as required