Director, Good Clinical Practice Quality Assurance

Job DetailsNon-Solicitation Policy and Notice to Agencies and Recruiters: IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@. We ask that you only email your interest once.Job Summary About IDEAYA Biosciences: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. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. 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 .Location: South San Francisco, CA.Position Summary:We are seeking a Director of Good Clinical Practice Quality Assurance to join our IDEAYA Quality Team. The Director of GCP QA is a leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP). This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials. The candidate will provide strategic leadership, drive continuous improvement initiatives, accountable for quality oversight of contract organizations, and ensure the highest standards of quality and patient safety in clinical research activities. The candidate will represent QA and function as the GCP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP) oversight for all Ideaya Bio. clinical studies. This position will report to the Vice President, Quality.This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.Job Description What you'll do: Lead and manage GCP audits, including clinical investigator sites, vendors, clinical trial documentation, and internal processes.Host and support regulatory inspections (i.e., BIMO, PV), partner audits and due diligence activities ensuring inspection readiness and timely resolution of findings.Review and approve audit reports, CAPA and quality action plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.Develop and implement the global GCP QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.Function as the Clinical QA Lead on all Ideaya Clinical study, represent QA in joint and steering committees including making key decisions on all GCP events.Oversee the development, implementation, and maintenance of GCP QA policies, procedures, and systems.Support the development and review of clinical trial protocols, informed consent forms, and other critical study related documents.Review and approve key documents, study protocol, monitoring plans, contracts and all study related essential documents.Ensure Ideaya clinical studies are in compliance with global GCP regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company standards.Compile, track GCP quality metrics (KPI) and vendor performance on all Ideaya initiated clinical studies and report to management on a quarterly basis.Identify, assess, and mitigate GLP/GCP-related compliance risks across clinical development programs including escalation of critical quality events to sr. management.Collaborate with clinical operations, regulatory affairs, and other stakeholders to address quality events and drive continuous improvement.Partner with clinical development, regulatory affairs, pharmacovigilance, and other functions to ensure alignment on quality and compliance objectives.Partner with clinical operations in selection of CRO's and other clinical service providers including managing the qualification and ongoing monitoring of GCP vendors, including CROs, central labs, and clinical service providers.Ensure contract research vendor compliance with contractual obligations, agreements, and regulatory requirements.Build, mentor, and lead a high-performing GCP QA team. Provide training and development opportunities to enhance team capabilities.Foster a culture of quality, accountability, and collaboration within the team and across the organization.Provide expert guidance on GCP regulations, guidance and compliance to senior management and cross-functional teams.Requirements:Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 10 years' experience working in GCP QA or clinical quality leadership roles.Minimum of 5+ years' experience hosting regulatory BIMO inspections (e.g., FDA, EMA, PMDA) and managing GCP audit programs.Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings.Flexibility to work in a fast-paced, dynamic environment with evolving priorities.Must be able to effectively collaborate with peers and comfortable working in a matrix team structure.Preferred Skills:Preferred background of oncology and/or early phase R&DTotal RewardsAlong with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.The expected salary range for the roleof Director, Good Clinical Practice Quality Assurance is $193,000- $238,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.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. This position requires you to work onsite in the office at the Company's facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.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.CompanyFounded in 2015, IDEAYA Biosciences is a public, clinical-stage synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality - which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. Stock Symbol: IDYACompany info Website Phone 650-443-6209 Location 7000 Shoreline CourtSuite 350 South San Francisco California 94080 USShare this job Facebook Twitter LinkedIn

Created: 2025-09-27