Vice President, Quality - IDEAYA Biosciences : Job Details

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, Amgen, Pfizer, and Gilead but wholly-owns or controls its three 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 [email protected]

Position Summary:

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 our South San Francisco headquarter or San Diego office and required to be onsite four days per week per our company policy.

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.

Requirements:

* 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 (