BioSpace
Director, Good Clinical Practice Quality Assurance
BioSpace, South San Francisco, California, us, 94083
Director, Good Clinical Practice Quality Assurance
Overview
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, 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 QA lead and accountable for GCP, GVP, GCLP oversight for all IDEAYA clinical studies. This position will report to the Vice President, Quality. This position is based in our South San Francisco headquarters and is onsite four days per week per our company policy.
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 studies, 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 CROs 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.
Qualifications
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
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, discretionary short-term incentive plan participation, and discretionary stock option awards (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 is $193,000-$238,000. The final salary offered will depend on several factors including location, experience, disease area, and interview performance.
EEO and Vaccination Notice The Company complies with all laws respecting equal employment opportunities and does not discriminate on protected characteristics. This position requires onsite work and full vaccination against COVID-19, subject to reasonable accommodations and applicable law. The Company considers you fully vaccinated 14 days after final vaccine dose, per FDA/WHO guidance. IDEAYA is an equal opportunity employer. EOE/AA/Vets.
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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 studies, 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 CROs 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.
Qualifications
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
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, discretionary short-term incentive plan participation, and discretionary stock option awards (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 is $193,000-$238,000. The final salary offered will depend on several factors including location, experience, disease area, and interview performance.
EEO and Vaccination Notice The Company complies with all laws respecting equal employment opportunities and does not discriminate on protected characteristics. This position requires onsite work and full vaccination against COVID-19, subject to reasonable accommodations and applicable law. The Company considers you fully vaccinated 14 days after final vaccine dose, per FDA/WHO guidance. IDEAYA is an equal opportunity employer. EOE/AA/Vets.
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