Associate Director, Quality Management System

About the role

IDEAYA is seeking a talented and highly motivated Associate Director, Quality Management Systems (QMS) with a passion for new cancer therapy development. This role will be responsible for leading the QMS function and for all Quality systems (GMP, GCP and GLP), as well as the implementation and oversight of EQMS, corporate quality policies and procedures.

Responsibilities

• Driving the development of the company's Quality Management Systems (QMS) strategy and policies.
• Overseeing company-wide documentation practices, record keeping, training, quality systems, and risk assessment, as related to compliance with internal and external clinical, safety, quality, and regulatory standards.
• Leading the implementation and continuous improvement of Veeva Quality Docs, Training, and QMS modules.
• Leading the QMS function and managing QMS SME consultants.
• Owner of Document Control, Training, Change Management, Deviation/CAPA, Customer Complaints, and associated quality systems.
• Creation, review and modification of Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Developing and overseeing robust and sustainable phase appropriate quality systems to ensure that manufacturing and quality control activities are conducted in compliance with current GxP guidelines.
• Developing and implementing continuous improvements, phase appropriate Quality Metrics, lead routine Senior Management Reviews and Annual Product Reviews.
• Assisting with service provider oversight, including qualification, routine audits and vendor quality management plans.
• Aiding in the oversight of internal and external audits to assess and ensure compliance with GxP regulatory requirements; implementing corrective actions to resolve audit findings.
• Ensuring that the company is inspection ready and providing guidance and support during regulatory inspections.
• Collaborating with functional leads and/or stakeholders on conducting routine risk assessments for clinical development and manufacturing activities including service provider oversight and trial conduct.
• Facilitating training on Quality systems, policies and SOPs for employees and GxP contractors.

Requirements

• BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree(s) preferred.
• Position requires a seasoned Quality professional with a minimum of eight [8] years of experience in biopharmaceutical companies with strong working knowledge in all GxP disciplines.
• Must have successful track record of implementing EQMS, preferred Veeva Quality Docs and QMS or other electronic systems.
• Working knowledge of Veeva workflows and configurations to enable efficient and compliant Veeva improvement projects.
• Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development, clinical manufacturing and commercial operations.
• Knowledge of and ability to apply GxP, FDA, EU and ICH regulations and guidelines.
• Proven expertise in the design and implementation of quality processes.
• Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
• Ability to effectively relate the quality functions to the business as a whole.
• Results-oriented team player; enjoys working collaboratively with colleagues and building positive relationships.
• Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment.
• Excellent verbal & written communication skills.