Our client is a clinical-stage biotechnology company seeking an experienced and highly motivated Senior GCP Quality Assurance Consultant to provide strategic and hands-on quality leadership supporting global Phase 3 clinical development programs.

This consultant will serve as a key member of the Quality organization and will be responsible for ensuring GCP compliance, inspection readiness, vendor oversight, and quality management activities across ongoing and upcoming pivotal studies. The ideal candidate is an experienced GCP QA professional who thrives in fast-paced biotech environments, enjoys rolling up their sleeves to execute operational activities, and possesses the creativity and flexibility to develop practical solutions to complex challenges.

This is a full-time consulting engagement expected to require 100% utilization over an initial 12-month period.

Key Responsibilities:

GCP Quality Oversight

• Provide strategic and operational GCP Quality Assurance support for global Phase 3 clinical programs.
• Partner closely with Clinical Operations, Clinical Development, Drug Safety, Regulatory Affairs, Data Management, and external vendors to ensure compliance with ICH-GCP guidelines, company SOPs, and applicable global regulations.
• Support the development and implementation of quality strategies that enable efficient execution of pivotal clinical studies.
• Serve as a quality advisor to study teams, providing guidance on GCP requirements, inspection readiness, and risk mitigation activities.

Vendor Management & Quality Agreements

• Provide oversight of CROs, central laboratories, imaging vendors, eCOA providers, and other clinical service providers supporting global studies.
• Review and assess vendor qualification packages, audit reports, and ongoing vendor performance metrics.
• Participate in vendor governance meetings and quality reviews to ensure compliance with sponsor expectations.
• Draft, review, negotiate, and maintain Quality Agreements with external vendors and service providers.
• Ensure appropriate quality oversight frameworks are in place throughout the lifecycle of vendor engagements.

Data Integrity & Compliance

• Support initiatives to ensure data integrity principles are maintained across clinical systems, vendors, and study activities.
• Assess processes and controls related to data collection, review, reconciliation, and reporting activities.
• Identify gaps and recommend pragmatic, risk-based solutions to strengthen data reliability, traceability, and inspection readiness.
• Collaborate with Clinical Data Management and Biometrics teams to ensure compliance with applicable regulations and industry best practices.

Inspection Readiness & Audits

• Lead and coordinate inspection readiness activities for ongoing and planned Phase 3 studies.
• Conduct and manage investigator site audits, vendor audits, internal process audits, and study-specific audits.
• Facilitate audit observations, CAPA development, effectiveness checks, and issue resolution activities.
• Support regulatory inspections and sponsor inspections, including preparation of teams, documentation reviews, and management of inspection responses.

Quality Systems & Continuous Improvement

• Review and assess existing quality systems, procedures, and processes to identify opportunities for enhancement.
• Recommend and implement pragmatic, risk-based improvements to support an evolving clinical development organization.
• Assist in authoring, revising, and maintaining SOPs, work instructions, and quality-related documentation.
• Develop tools and approaches that improve operational efficiency while maintaining compliance.

Qualifications:

Required

• Bachelor's degree in Life Sciences or related discipline.
• 10+ years of Quality Assurance experience within biotechnology, pharmaceutical, or CRO environments.
• Extensive experience supporting global Phase 3 clinical studies.
• Deep knowledge of ICH-GCP guidelines, FDA regulations, and global regulatory requirements.
• Demonstrated success preparing organizations for inspections and managing audit activities.
• Significant experience overseeing CROs and clinical vendors, including development and management of Quality Agreements.
• Strong understanding of data integrity expectations and risk-based quality management principles.
• Proven ability to work independently and effectively within lean, fast-paced biotech environments.
• Strong problem-solving skills with a practical, solutions-oriented mindset.
• Excellent communication, organizational, and stakeholder management skills.

Preferred

• Prior experience serving as a senior or lead GCP QA professional within a small or emerging biotechnology company.
• Experience supporting cardiovascular, rare disease, or other complex therapeutic area programs.
• Experience supporting clinical studies conducted in China or working with Chinese investigative sites, vendors, and regulatory requirements is highly desirable.
• Eastern Time Zone availability preferred.
• Ability to balance strategic thinking with a willingness to execute day-to-day activities and deliverables.