Associate Director, Quality Management System

IDEAYA Biosciences • South San Francisco, CA

2d • $171,000 - $211,000 • Hybrid

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. 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. Location: South San Francisco, CA. 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. They will substantially strengthen quality systems and determine the appropriate infrastructure and resources required to achieve business objectives. This person will need to work with functional groups in an integrated way to support the delivery of the company’s business goals. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

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.
• All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.
• Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Nice To Haves

• Advanced Degree (s) preferred

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.
• Lead 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 Compliant, 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.
• Develop and implement continuous improvements, phase appropriate Quality Metrics, lead routine Sr. Management Review and Annual Product Review.
• Assisting with service provider oversight, including qualification, routine audits and vendor quality management plans
• Assist 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
• Collaborate 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

Benefits

• merit-based salary increases
• company discretionary short-term incentive plan participation
• company discretionary stock option awards
• medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager