Senior Director/Vice President, Quality
Sales & Business Development, Quality Assurance
South San Francisco, CA, USA
Posted on Wednesday, July 26, 2023
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-owner controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen and Pfizer 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.
This position will develop, manage, and improve existing quality systems to ensure appropriate controls for IDEAYA’s in-house GxP capabilities. This includes the expansion of existing Quality Management System (QMS), development of documents, training of personnel, and quality oversight of contract manufacturers and clinical development. The Head of Quality will be responsible for QA aspects of vendor oversight including audits, establishment of Quality Agreements, major deviation review, and batch disposition/release. Head of Quality shall be responsible for both Pre-Approval Inspections and BioResearch Monitoring Program (BIMO) inspection readiness, as well as QA support of post approval pharmacovigilance systems. Knowledge of computerized system validation and Annex 11/Part 11 is critical to success in the role.
This position is based in South San Francisco, CA. or San Diego, CA.
What you'll do:
- Manage, develop, and build a high-performing Quality organization and its capabilities with a goal of creating a Quality oriented approach company wide.
- Support program teams as a subject matter expert; provide direction on interpretation and application of global quality regulations and guidance documents.
- Take an active mentorship approach in developing the team to best serve the business.
- Set short-term and long-term goals that are aligned with IDEAYA’s Corporate and Quality goals.
- Maintain Quality oversight of all GxP activities, key metrics of performance and provide regular updates to the IDEAYA’s Executive Leadership.
- Provide leadership, direction and oversight for the selection, development, and implementation of robust Quality Systems and cross functional polices related to GxP compliance, including quality standards and SOPs.
- Execute on all aspects of the Quality Management System including Audit planning and Execution, CAPA, Good Documentation Practice, GXP System Validation, Inspection Readiness Issue Management, Process Development, Risk Management and Training.
- Chair of the Quality Management Committee and final decision-maker on all quality aspects including recall of products as necessary.
- Build strong relationships with key cross-functional stakeholders including Clinical Operations and Data Management, CMC (technical operations, supply chain, analytical development), Regulatory and Project Management.
- Oversee the planning and conduct of internal and external audits to ensure compliance with regulatory requirements for clinical trials and for investigational drug manufacturing, and ensure corrective actions are implemented to resolve audit findings.
- Monitors industry best practices, changes in global regulations and guidelines for marketed and investigational projects and ensures operational compliance with regulatory requirements, creating an “inspection-ready” environment across the company.
- Accountable for the development and management of departmental budget.
- BS/ MS in a scientific discipline (e.g. Microbiology, Biochemistry), BS (15+ yrs. experience), MS (10+yrs experience)
- Minimum 12 years of Quality Assurance experience with a minimum of 6 years in CQA leadership positions
- Ability to quickly establish credibility with diverse audiences and be perceived as a leader.
- Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.
- Must have experience in smaller organizations supporting the development of novel technologies and/or products, to support creative problem solving
- Provides quality oversight for oncology clinical trials
- Must have a proven track record of leadership across multiple GxP processes. Ensures compliance with GxP, cGMP, GCP, and other regulatory requirements, people management, and effective interpersonal and communication skills
- Be responsible for translating quality strategy into plans of action.
- Must have deep knowledge of cGxP requirements with an understanding of phase-appropriate clinical and commercial expectations with the ability to prioritize and manage through complex processes/projects
- Ideal candidate will possess a “happy-warrior” attitude with a focus on team success, within Quality as well as with cross-functional business partners.
- Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
- Experience with GMP and GCP FDA, QP and EMA/MHRA inspections and audits.
- Ability to travel both domestically and internationally (<20%)
The salary range for this position at the Senior Director level is between $246,000 and $270,905. The salary range is an estimate and may vary based on the Company’s compensation practices.
The salary range for this position at the Vice President level is between $282,800 and $346,000. 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.
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.