Chief Quality Partner, Clinical Development (GCP/GVP)

Discover International; New Jersey; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Discover International is seeking an AD-VP, Clinical Quality Assurance (GCP/GVP) to lead global clinical quality programs. This role partners with Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, and external providers to uphold regulatory standards and drive continuous quality improvements.

The ideal leader brings strong GCP/GVP expertise, a risk-based mindset, and a proven ability to guide cross-functional teams toward inspection readiness and robust CAPA processes.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field required.
• 8+ years of experience in Clinical Quality Assurance, Clinical Research, Pharmacovigilance, or a related pharmaceutical/biotechnology function.
• 5+ years of direct GCP Quality Assurance experience.
• Demonstrated experience leading GCP audits, vendor audits, and inspection readiness activities.
• Experience supporting regulatory authority inspections.
• Experience working within global clinical development environments.
• Experience overseeing outsourced service providers, CROs, and/or other external partners.
• Oncology clinical development experience strongly preferred.
• Strong knowledge of GCP/GVP regulations, quality systems, risk management, and audit practices.
• Excellent communication, collaboration, and organizational skills.
• Competitive compensation and comprehensive benefits.
• Opportunities for professional growth and career development.
• Collaborative environment within a growing biopharmaceutical organization.
• Opportunity to contribute to innovative clinical development programs and initiatives focused on improving patient outcomes.

Responsibilities

• Quality guidance to ensure global GCP and GVP compliance.
• Develop and improve clinical quality systems.
• Lead quality risk assessments and mitigation strategies.
• Monitor regulatory expectations and best practices.
• Develop and execute risk-based GCP/GVP audit programs.
• Oversee audits of internal teams, vendors, CROs, and pharmacovigilance.
• Evaluate audit findings and implement remediations.
• Coordinate inspection readiness activities and responses.
• Lead investigations into deviations and CAPA activities.
• Monitor quality events and CAPA metrics for trends.
• Provide quality oversight for CROs, pharmacovigilance vendors, labs, and tech providers.
• Support vendor qualification and governance activities.
• Establish and monitor quality metrics and RBQM strategies.
• Lead creation and lifecycle management of GCP/GVP SOPs and training.
• Mentor junior quality professionals and support strategic objectives.
• Contribute to long-term Clinical Quality strategy and resource planning.

Skills

GCP QA

GVP

Regulatory compliance

Audit management

Inspection readiness

Risk management

Vendor oversight

Cross-functional collaboration

Oncology domain

Education

Bachelor's degree in Life Sciences or related field

Job description

Discover International is seeking an AD-VP, Clinical Quality Assurance (GCP/GVP) to lead global clinical quality programs. This role partners with Clinical Operations, Pharmacovigilance, Regulatory Affairs, Biometrics, and external providers to uphold regulatory standards and drive continuous quality improvements.

The ideal leader brings strong GCP/GVP expertise, a risk-based mindset, and a proven ability to guide cross-functional teams toward inspection readiness and robust CAPA processes.