AD-VP Clinical Quality Assurance

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

AD/D/SD/VP Clinical Quality Assurance (GCP/GVP)

A growing clinical-stage biopharmaceutical organization is seeking an AD-VP, Clinical Quality Assurance (GCP/GVP) to provide strategic leadership and oversight of clinical quality programs across global development activities.

This individual will help ensure compliance with applicable Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory requirements, and internal quality standards. The role will partner closely with Clinical Operations, Pharmacovigilance/Drug Safety, Regulatory Affairs, Biometrics, and external service providers to support quality systems, risk management, inspection readiness, and continuous improvement.

The ideal candidate will bring strong GCP Quality Assurance experience, a risk-based mindset, and the ability to serve as a trusted quality partner across cross-functional development teams.

This is a hybrid position with an expectation of working onsite approximately 2–3 days per week.

Responsibilities

Quality Systems & Compliance

• Provide quality guidance to ensure compliance with global GCP and GVP regulations, guidelines, and industry standards.
• Support the development, implementation, and continuous improvement of clinical quality systems.
• Lead quality risk assessments and development of appropriate risk mitigation strategies.
• Monitor evolving regulatory expectations and industry best practices.

Audit Program Management

• Develop and execute risk-based GCP/GVP audit programs.
• Lead and/or oversee internal, investigator site, vendor, CRO, and pharmacovigilance audits.
• Evaluate audit findings and ensure appropriate remediation activities are implemented.
• Identify compliance trends and recommend quality improvements.

Inspection Readiness

• Lead inspection readiness activities across clinical development and pharmacovigilance functions.
• Support regulatory agency inspections and sponsor audits.
• Coordinate inspection preparation, mock inspections, and readiness assessments.
• Provide quality guidance during inspections and support effective management of inspection responses.

CAPA & Quality Event Management

• Oversee investigations related to deviations, non-compliance events, audit findings, and inspection observations.
• Facilitate root cause analysis and ensure appropriate CAPAs are developed, implemented, and assessed for effectiveness.
• Monitor quality events and CAPA metrics to identify trends and opportunities for improvement.

Vendor Quality Oversight

• Provide quality oversight for CROs, pharmacovigilance vendors, laboratories, technology providers, and other outsourced service providers.
• Support vendor qualification, risk assessments, audits, and ongoing performance monitoring.
• Provide quality input into vendor selection and governance activities.
• Ensure outsourced activities meet applicable regulatory and quality standards.

Quality Metrics & Risk-Based Quality Management

• Establish and monitor key quality metrics and compliance indicators.
• Analyze quality data to identify emerging risks and systemic trends.
• Support Risk-Based Quality Management (RBQM) strategies and Quality Tolerance Limits (QTLs).
• Communicate quality metrics and compliance status to senior leadership.

SOPs & Training

• Lead development, review, and lifecycle management of GCP, GVP, and Clinical Quality SOPs and procedures.
• Develop and deliver quality training programs.
• Provide quality consultation and mentoring to cross-functional teams.
• Promote a culture of quality, compliance, and inspection readiness.

Leadership & Strategic Partnership

• Serve as a trusted quality advisor to clinical development teams.
• Lead cross-functional quality initiatives aligned with organizational objectives.
• Mentor junior quality professionals and contribute to development of team capabilities.
• Support long-term Clinical Quality strategy, resource planning, and operational excellence initiatives.

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.