Director, Good Clinical Practice Quality Assurance

Job Summary

ABOUT IDEAYA:

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.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to [email protected]

Position Summary

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 or San Diego office 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&D
  
  
  

Salary Range: $192,780 - $238,140

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in ourSouth San Francisco or San Diego, California office is $192,780 - $238,140The 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.