BioSpace
Director, Good Manufacturing Processes, Quality Assurance
BioSpace, South San Francisco, California, us, 94083
Director, Good Manufacturing Processes, Quality Assurance
Location: South San Francisco, CA.
Job Summary 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 teamwork to move science forward.
Position Summary We are seeking a Director of Good Manufacturing Processes, Quality Assurance to join our IDEAYA Quality team. The Director, GMP, Quality Assurance will lead GMP QA oversight for drug products and biologics programs from toxicology through Phase 3. This role ensures phase‑appropriate GMP compliance across CMC, manufacturing development, and IT Systems, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This position is based in our South San Francisco headquarters and requires onsite presence four days per week per company policy. Reporting to: Vice President, Quality.
Job Description What you’ll do:
Collaborate to 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 DS/DP 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, analytical, and including review and approval of deviations, CAPAs, change controls, and protocol/reports.
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 (vendors) used 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 (vendor) qualification activities to ensure phase‑appropriate compliance.
Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, formulation work, scale‑up (commercialization), and computer systems validation.
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 (e.g., IND, IMPD, BLA sections) 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.
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.
Additional responsibilities and duties as assigned.
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; advanced degree may substitute for years of experience.
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.
Experience supporting regulatory submissions (e.g. IND, IMPD, BLA/MAA, NDA) with high‑quality documentation and Quality strategy input.
Exceptional leadership and team‑building skills, strong analytical, problem‑solving, and decision‑making abilities.
Effective communicator and cross‑functional collaborator with the ability to influence across technical and strategic levels.
Highly organized, with sharp attention to detail, analytical thinking, and strong decision‑making skills.
Proficient in Microsoft Office and quality system tools (e.g. Veeva, ACE Inspection, etc.), Microsoft SharePoint, Microsoft Visio, and Egnyte.
Strong knowledge of computer system validation processes is preferred.
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 role of Director, Good Manufacturing Processes, Quality Assurance is $200,000 – $247,000. 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 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.
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Job Summary 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 teamwork to move science forward.
Position Summary We are seeking a Director of Good Manufacturing Processes, Quality Assurance to join our IDEAYA Quality team. The Director, GMP, Quality Assurance will lead GMP QA oversight for drug products and biologics programs from toxicology through Phase 3. This role ensures phase‑appropriate GMP compliance across CMC, manufacturing development, and IT Systems, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This position is based in our South San Francisco headquarters and requires onsite presence four days per week per company policy. Reporting to: Vice President, Quality.
Job Description What you’ll do:
Collaborate to 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 DS/DP 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, analytical, and including review and approval of deviations, CAPAs, change controls, and protocol/reports.
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 (vendors) used 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 (vendor) qualification activities to ensure phase‑appropriate compliance.
Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, formulation work, scale‑up (commercialization), and computer systems validation.
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 (e.g., IND, IMPD, BLA sections) 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.
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.
Additional responsibilities and duties as assigned.
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; advanced degree may substitute for years of experience.
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.
Experience supporting regulatory submissions (e.g. IND, IMPD, BLA/MAA, NDA) with high‑quality documentation and Quality strategy input.
Exceptional leadership and team‑building skills, strong analytical, problem‑solving, and decision‑making abilities.
Effective communicator and cross‑functional collaborator with the ability to influence across technical and strategic levels.
Highly organized, with sharp attention to detail, analytical thinking, and strong decision‑making skills.
Proficient in Microsoft Office and quality system tools (e.g. Veeva, ACE Inspection, etc.), Microsoft SharePoint, Microsoft Visio, and Egnyte.
Strong knowledge of computer system validation processes is preferred.
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 role of Director, Good Manufacturing Processes, Quality Assurance is $200,000 – $247,000. 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 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.
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