Senior Director, Good Clinical Practice & Good Pharmacovigilance Practice Quality Assurance

IDEAYA Biosciences; South San Francisco (CA); On-site; USD 228,000 - 282,000; Full time

Job summary

An established industry player is seeking a Senior Director for Good Clinical Practice and Pharmacovigilance Quality Assurance. This pivotal role involves overseeing quality assurance activities, ensuring compliance with global regulations, and leading a high-performing QA team. The ideal candidate will have extensive experience in the pharma or biotech sectors, particularly in oncology, and a proven track record in regulatory inspections and GCP audits. Join a passionate team dedicated to advancing precision medicine and making a significant impact on cancer therapy.

Qualifications

• 15+ years in pharma/biotech, with 10+ years in GCP QA or clinical quality leadership.
• Strong knowledge of GCP regulations and clinical trial processes.

Responsibilities

• Oversee quality assurance activities related to GCP and GVP.
• Lead a team of QA professionals ensuring compliance with global regulatory requirements.
• Develop and implement global GCP QA strategy aligned with corporate goals.

Skills

Good Clinical Practice (GCP)

Good Pharmacovigilance Practice (GVP)

Quality Assurance Leadership

Regulatory Compliance

Clinical Trial Processes

Analytical Skills

Education

Advanced degree in life sciences, pharmacy, or chemistry

Job description

Senior Director, Good Clinical Practice & Good Pharmacovigilance Practice Quality Assurance

2 weeks ago Be among the first 25 applicants

This range is provided by IDEAYA Biosciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$228,098.00/yr - $281,768.00/yr

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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. IDEAYA has established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.

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. For more information, please see www.ideayabio.com.

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 [e-mail]

Position Summary

The Sr. Director of GCP & GVP QA is a senior 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 lead a team of QA professionals, provide strategic leadership, drive continuous improvement initiatives, be 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 & GVP QA lead and be accountable for GCP, GVP, GCLP oversight for all IDEAYA Bio. clinical studies. This position will report to the Vice President of QA.

This position is based in our South San Francisco headquarters and requires onsite presence four days per week as per company policy.

What you'll do

1. Develop and implement the global GCP QA strategy aligned with corporate goals, SOPs, and global regulatory requirements
2. Function as the Clinical QA Lead on all IDEAYA clinical studies, representing QA in joint and steering committees, including making key decisions on GCP events
3. Oversee the development, implementation, and maintenance of GCP QA policies, procedures, and systems
4. Support the development and review of clinical trial protocols, informed consent forms, and other critical study documents
5. Review and approve key documents such as study protocols, monitoring plans, contracts, and essential study documents
6. Ensure compliance of clinical studies with global GCP regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company standards
7. Compile, track, and report GCP quality metrics (KPIs) and vendor performance on all clinical studies quarterly
8. Lead and manage GCP audits, including sites, vendors, documentation, and internal processes
9. Support regulatory inspections, partner audits, and due diligence activities, ensuring inspection readiness and timely resolution of findings
10. Review audit reports, CAPAs, and quality action plans, ensuring effective resolution of non-conformance and quality events
11. Identify, assess, and mitigate GLP/GCP compliance risks across programs, escalating critical quality issues to senior management
12. Collaborate with clinical operations, regulatory affairs, and other stakeholders to address quality events and drive improvements
13. Partner with clinical development, regulatory, and pharmacovigilance teams to align on quality and compliance objectives
14. Assist in the selection and monitoring of CROs and other vendors, ensuring contractual and regulatory compliance
15. Build, mentor, and lead a high-performing GCP QA team, providing training and development opportunities
16. Foster a culture of quality, accountability, and collaboration within the team and organization
17. Provide expert guidance on GCP regulations and compliance to senior management and cross-functional teams

Requirements

• Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS, or equivalent preferred)
• At least 15 years of experience in pharma or biotech, with 10+ years in GCP QA or clinical quality leadership
• 5+ years hosting regulatory inspections (FDA, EMA, PMDA) and managing GCP audit programs
• Proven track record in leading GCP QA functions within a global organization, preferably oncology
• Strong knowledge of GCP regulations, ICH guidelines, and clinical trial processes
• Excellent leadership, communication, and stakeholder influence skills
• Analytical mindset focused on continuous improvement and innovation; occasional travel (up to 20%) may be required
• Ability to work effectively in a fast-paced, dynamic, matrix environment

Preferred Skills

• Background in oncology and/or early phase R&D (preferred)