Director of Clinical Quality Assurance

Precision Point; San Francisco (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Precision Point is seeking a Director, Clinical Quality Assurance to build and lead the GCP quality function across the Phase III oncology portfolio. Reporting to the VP, this leader ensures studies comply with ICH E6(R3), FDA, EMA, and global regulations, ensuring credible, inspection-ready data.

This hands-on leadership role involves building systems from the ground up and partnering with Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance as programs advance toward

Qualifications

• Bachelor's degree in life science, nursing, pharmacy, or related field; advanced degree preferred.
• 10+ years in biopharmaceutical industry, with at least 7 years in GCP Quality Assurance.
• Hands-on oncology clinical trial experience, spanning early phase through registrational studies.
• Deep working knowledge of ICH E6(R3), 21 CFR Parts 11, 50, 54, 56, 312, and EU CTR.
• Proven track record leading GCP audits of investigator sites, CROs, and vendors.
• Direct experience supporting FDA BIMO and/or EMA inspections.
• Strong judgment, communication, and influencing skills with the ability to partner across functions at all levels.

Responsibilities

• Develop and execute a risk based clinical quality strategy aligned with ICH E6(R3) and development plans.
• Build, maintain, and continuously improve GCP SOPs, work instructions, and QA components of the QMS.
• Define quality metrics and indicators, and report trends and risks to senior leadership.
• Plan and manage the annual GCP audit program across sites, CROs, labs, IRT, and other vendors.
• Conduct and oversee audits of trial master files, clinical study reports, and regulatory submission documents.
• Lead quality qualification and ongoing oversight of CROs and clinical vendors, including quality agreements.
• Own inspection readiness for FDA BIMO, EMA, and other health authority inspections.

Skills

GCP quality assurance

Audit program management

Vendor and CRO oversight

Inspection readiness

Deviations, CAPA, and compliance

Leadership and training

Cross-functional collaboration

Education

Bachelor's degree in life sciences / nursing / pharmacy or related field

Advanced degree preferred

Tools

eClinical systems

Job description

The Director, Clinical Quality Assurance will build and lead the GCP quality function across our Phase III oncology clinical portfolio. Reporting to the [VP, Quality / Head of Quality], this leader ensures every study is conducted in compliance with ICH E6(R3), FDA, EMA, and applicable global regulations, and that our trial data is credible and inspection ready.

This is a hands on leadership role for someone who enjoys building systems from the ground up, partnering closely with Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and Pharmacovigilance as our programs advance toward registration.

Key Responsibilities

Clinical Quality Strategy and Systems

• Develop and execute a risk based clinical quality strategy aligned with ICH E6(R3) and the company's development plans
• Build, maintain, and continuously improve GCP SOPs, work instructions, and the clinical components of the Quality Management System
• Define quality metrics and key risk indicators, and report trends and risks to senior leadership

Audit Program

• Plan and manage the annual GCP audit program, including investigator sites, CROs, central and specialty labs, IRT, eClinical systems, and other critical vendors
• Conduct and oversee audits of trial master files, clinical study reports, and regulatory submission documents
• Manage external auditors and consultants as needed

Vendor and CRO Oversight

• Lead quality qualification and ongoing oversight of CROs and clinical vendors, including quality agreements
• Partner with Clinical Operations on risk based monitoring plans and issue escalation

Inspection Readiness

• Own inspection readiness for FDA BIMO, EMA, and other health authority inspections, including mock inspections, storyboards, and front room and back room management
• Prepare sites, CROs, and internal teams ahead of pivotal study and BLA/NDA related inspections

Deviations, CAPA, and Compliance

• Oversee management of protocol deviations, serious breaches, quality issues, and CAPAs through effective root cause analysis
• Review protocols, ICFs, monitoring plans, and data management plans for quality and compliance
• Provide GCP guidance on oncology specific considerations such as complex dose escalation designs, expansion cohorts, and biomarker driven studies

Leadership and Training

• Build and mentor a high performing clinical QA team as the portfolio grows
• Deliver GCP training and foster a culture of quality and accountability across the organization

Required

• Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree preferred
• 10+ years of experience in the biopharmaceutical industry, with at least 7 years in GCP Quality Assurance
• Hands on oncology clinical trial experience, ideally spanning early phase through registrational studies
• Deep working knowledge of ICH E6(R3), 21 CFR Parts 11, 50, 54, 56, 312, and EU CTR
• Proven track record leading GCP audits of investigator sites, CROs, and vendors
• Direct experience supporting FDA BIMO and/or EMA inspections
• Strong judgment, communication, and influencing skills with the ability to partner across functions at all levels

Preferred

• Experience supporting a BLA or NDA submission and preapproval inspections
• Background building a clinical QA function at a small or mid sized biotech