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.
• 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.
• 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.
• Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
• 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.

Qualifications

• Seasoned Quality professional with a 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.
• 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.
• Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
• 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.

Skills

• Strong leadership and project management skills.
• Excellent interpersonal and communication skills.
• Strong problem-solving and analytical skills.
• Ability to manage multiple priorities and deadlines.
• Strong knowledge of GxP regulations and guidelines.
• Experience with Veeva Quality Docs and QMS systems.

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). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

Pay

The expected salary range for the role of Associate Director, Quality Management Systems (QMS) is $171,000 - $211,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

Schedule

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.