Senior Director, Quality Assurance Compliance

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs.  It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.

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.

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 HR@ideayabio.com

Position Summary:

Reporting to the Vice President of Quality Assurance, the Senior Director of QA Compliance will provide leadership, direction and oversight of Quality compliance activities.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

• Provides leadership, direction, and oversight of Quality Compliance activities, including risk management & escalation, regulatory inspection / partner audit management, internal & external audit program, quality vendor management, quality metrics, management review, and annual compliance training.
• Works directly with Quality colleagues to identify, prioritize and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable regulations.
• Work closely with Project Teams to ensure adherence to the Quality Management System, SOPs, and regulations/guidelines.
• Develop, implement and manage inspection readiness activities to support regulatory inspections and partner audits.
• Provide strategic direction and leadership of the Vendor Qualification program including external auditing.
• Develops and manages Quality Council and Quality Management Review programs including the development of quality metrics.
• Identifies and implements compliance training for company staff supporting GxP activities and processes.
• Improves, implements, and manages effective risk escalation processes.
• Support the development of the company’s Quality strategy and policies.
• Communicates with and influences internal and external customers across the company to ensure compliant and aligned resolution of project related issues and investigations.
• Develop presentation materials and present to senior management.
• Support Business Development and Due Diligence efforts.
• Other related duties as assigned.

• Bachelor of Arts/Bachelor of Science in a related discipline.
• 12+ years of experience in quality assurance supporting GxP operations.
• Demonstrated experience in defining, developing and implementing Quality compliance processes supporting Late-Stage Clinical Development and Commercial activities.
• Strong Leadership Skills including strong teamwork, collaboration, transparent communication, integrity, change agent, developing people, leading by example.
• Experience with FDA/Health Authority inspection readiness and successful inspections, conducting QA audits, and working with pharmaceutical processes are required.
• Previous experience conducting compliance auditing of clinical sites, CROs, CMOs, laboratories and/or vendors, and detailed knowledge of regulated documentation systems is highly desirable.
• A strong working knowledge of cGMP, GCP, GLP, GvP, ICH guidelines, general compliance regulations and their application is necessary.
• Must be able to travel without any legal restrictions across international borders.

The salary range is an estimate and may vary based on the Company’s compensation practices.

The Company complies with all laws respecting equal employment opportunity 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 at the Company’s facilities, with partial 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.

Benefits

Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.

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.

California Job Applicant Privacy Notice