Director, Clinical Quality Assurance – GCP

Role Overview

• The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities
• Manage the GCP Quality interface and support for all Clinical Project Teams
• Identify and access compliance risk and develop and implement risk mitigation measures
• Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents
• Review and approve Clinical SOPs
• Develop and Implement Clinical QA SOPs
• Develop and implement detailed audit plans and yearly GCP audit schedules
• Ensure the timely and effective follow up of all identified or assigned quality issues
• Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested
• Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
• Direct and/or deliver yearly GCP training for internal staff as needed
• Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness
• Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies
• Provide management reports on audit strategy, plans, and findings
• Support process improvement initiatives; lead continuous improvements within Quality
• Maintain knowledge of GCP regulations, guidelines, company standards and procedures
• Preferred experience in providing oversight and supporting GLP related studies

Requirements

• 12+ years relevant work experience within the GxP (GCP heavy) Biotechnology/Pharmaceutical industry
• Scientific or engineering degree (BSc, MSc, PhD), Min Bachelor of Science Degree in Biology, Biomedical Engineering, Engineering, or equivalent
• Knowledge of Good Clinical Practice (GCP) FDA, MHRA and EMA regulatory requirements applicable to Biologics therapy products
• Very good scientific and medical/clinical expertise
• Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels
• Well organized and detail-oriented; must be able to effectively prioritize work
• Eager to learn, interact cooperatively and effectively with others in a team environment
• Possess advanced word processing, data entry and data presentation computer skills
• Ability to influence and work effectively with business partners across regions and cultures
• Displays organizational leadership qualities and effective coaching abilities
• Listening, interpreting, and summarizing information skills must be highly developed
• Ability to work both independently with direction and within project teams to attain goals
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs)
• Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
• Strong organizational skills and the ability to participate effectively cross-functionally
• Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment
• Fluency in written and spoken English
• Fluency in Chinese is a plus
• Demonstrated ability to lead on-site corporate, external, or Health Authority inspections
• A self-starter and a team player who thrives in a fast-paced dynamic team environment
• Proficiency in using Veeva Clinical and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
• Veeva Quality is a plus
• Certification as an auditor by an organization recognized is desirable within the pharmaceutical industry

Tech Stack

• Google Cloud Platform

Benefits

• Willingness to travel to various meetings/audits
• May require approximately 10-25% travel