Director, Clinical Quality Assurance - Contractor

Essential Duties & Responsibilities

• Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures.
• Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures.
• Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives.
• Establish/maintain the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
• Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and Clinical QA to Clinical QA meetings.
• Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
• Support inspection readiness, plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs.
• Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

Education & Experience

• Bachelor’s or advanced degree in Biology, Chemistry, or related field.
• Minimum 10 years of ICH-GCP/GVP Quality Assurance experience.
• Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes).
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.

Knowledge/Skills/Abilities

• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• About 15% travel required.