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About the Role

IDEAYA is a precision medicine oncology company dedicated to discovering, developing, and commercializing transformative cancer therapies. We integrate expertise in small-molecule drug discovery, structural biology, and bioinformatics with internal capabilities for identifying and validating translational biomarkers. Our mission is to develop tailored, potentially first-in-class targeted therapies for molecularly defined solid tumor indications, aiming to improve clinical outcomes for cancer patients. We foster a collaborative, data-driven, and inquisitive environment where brilliant minds work together to advance oncology medicine.

Responsibilities

Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.
Serve as the Quality lead for GMP activities supporting clinical trial materials, including drug substance/drug product used in early and late-phase studies.
Collaborate cross-functionally with Information Technology staff to support computer system validation activities.
Oversee QA support for development-stage manufacturing and analytical activities, including review and approval of deviations, CAPAs, and change controls.
Collaborate cross-functionally with CMC staff, Regulatory Affairs, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
Provide Quality oversight of contract development and manufacturing organizations (CDMOs) and other GxP service providers for clinical trial materials and services.
Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.
Lead or support Quality Agreements, risk assessments, audits, and service provider qualification activities to ensure phase-appropriate compliance.
Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, and formulation work.
Collaborate on phase-appropriate quality system improvements for development-stage programs.
Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.
Support regulatory submissions by reviewing or contributing Quality input and documentation.
Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
Support investigations and root cause analysis of product or process issues related to clinical manufacturing.
Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.
Responsible for final product Quality release/rejection and related processes.
Support service provider and internal audits as necessary.
Support oversight of Third-Party Logistics compliance.
Create and maintain Standard Operating Procedures related to areas of responsibility including product release, design control, and change management.
Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings.
Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
Act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies.
Demonstrate good judgment and ethical behavior, maintain patient and product safety as a top priority, and report any suspected violations.

Requirements

BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
Minimum of 12 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 8 years supporting development-stage programs.
Minimum 5 years of direct GxP experience (GMP, GCP, GPV, and/or GLP) in a regulated environment supporting small molecule drug products and biologics.
Minimum 3 years of direct GxP experience supporting computer systems validation.
Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Part 210/211, 600s, ICH, EU Annexes, GAMP5, ISO 9001, ISO 27001), and compliance expectations across clinical development.
Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and service provider management experience.
Proven track record and relevant industry experience in leading GMP QA functions within a global organization.
Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and pharmaceutical development.
Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.

Skills

GMP QA oversight
Drug product and biologics programs
Phase-appropriate GMP compliance
CMC
Manufacturing development
IT Systems
Quality strategy
Risk management
Regulatory readiness
Quality Agreements
Risk assessments
Audits
Service provider qualification
Technical development
Process development
Method validation/transfer
Batch record reviews
Formulation work
Clinical supply chain
Product quality resolution
Computer systems validation
Quality system improvements
Quality governance
Regulatory submissions (IND, IMPD, BLA)
Standard Operating Procedures (SOPs)
Root cause analysis
Lifecycle changes
Process optimizations
Continuous improvement
Product Quality release/rejection
Third-Party Logistics compliance
Design control
Change management
Technology transfer
Regulatory inspections
Global GMP regulations (FDA, EMA, PMDA, ICH Q7, Q10)

Location

South San Francisco, CA

Work Type

Onsite (four days per week)
Hybrid

Experience Level

Director level
Minimum 12 years of relevant Quality Assurance experience
Minimum 8 years supporting development-stage programs
Minimum 5 years direct GxP experience
Minimum 3 years direct GxP experience supporting computer systems validation

Education Level

BS degree in Life Sciences, Chemistry, Engineering, or related discipline
Advanced degree (MS, PhD, PharmD) strongly preferred

Salary/Compensations

$200,000 - $247,000

Benefits

Merit-based salary increases
Company discretionary short-term incentive plan participation
Company discretionary stock option awards
Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
401k
ESPP
Wellness programs

About the Company

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.
Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.
We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.
Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA.
We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward.
For more information, please see www.ideayabio.com.

Equal Opportunity

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.
IDEAYA is an equal opportunity employer.
In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.
EOE/AA/Vets.