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 provide 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.
• Minimum of eight [8] years of experience in biopharmaceutical companies with strong working knowledge in all GxP disciplines.
• 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.
• Broad understanding of contemporary quality practices as they apply to product development, clinical manufacturing and commercial operations.
• Proven expertise in the design and implementation of quality processes.
• Proven ability to work independently and flexibly in a fast-paced, high growth environment.
• Excellent verbal & written communication skills.

Qualifications

• Seasoned Quality professional with a minimum of eight [8] years of experience in biopharmaceutical companies with strong working knowledge in all GxP disciplines.
• Track record of success and a broad understanding of contemporary quality practices as they apply to product development, clinical manufacturing and commercial operations.
• Proven expertise in the design and implementation of quality processes.
• Proven ability to work independently and flexibly in a fast-paced, high growth environment.
• Excellent verbal & written communication skills.

Skills

• Strong working knowledge of Veeva workflows and configurations to enable efficient and compliant Veeva improvement projects.
• Proven expertise in the design and implementation of quality processes.
• Proven ability to work independently and flexibly in a fast-paced, high growth environment.
• Excellent verbal & written communication skills.

Benefits

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, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).

The Company complies with all laws respecting equal employment opportunities 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 in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as 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.

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.