Validation engineer serp_jobs.h1.location_city

Non-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@ideayabio.com. 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 www.ideayabio.com.

Location : South San Francisco, CA.

Position Summary :

We are seeking a Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action / Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. 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 :

• Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
• Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
• Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities.
• Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events.
• Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review).
• Monitor emerging regulatory trends and ensure proactive adaptation of QA processes.
• Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis.
• Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories.
• 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.
• Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
• Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance.
• Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends.
• Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes.
• Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
• Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement.
• Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
• Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives.
• Support the development and review of batch records, specifications, test methods, protocols, and other critical documents.
• Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories.
• Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

Requirements :

Preferred Skills :

Total Rewards

Along 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 Manufacturing Practices & Computer System Validation Quality Assurance is $187,000 - $231,000. 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.