Associate Director/Director, Quality
Ideaya Biosciences, United States
Job Description
About IDEAYA Biosciences:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see www.ideayabio.com.
Position Summary:
IDEAYA is seeking a talented and highly motivated Associate Director/Director, Quality with a passion for new cancer therapy development. This role will be responsible for leading the Quality function and for all Quality systems (GMP, GCP and GLP), as well as the implementation and oversight of 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.
What you’ll do:
- Driving the development of the company's Quality strategy and policies.
- Overseeing company-wide documentation practices, record keeping, training, auditing and risk assessment, as related to compliance with internal and external clinical, safety, quality, and regulatory standards.
- Leading the QA function and managing QA SME consultants
- Creation, review and modification of Standard Operating Procedures (SOPs) and Work Instructions (WI)
- Developing and overseeing robust and sustainable quality systems to ensure that manufacturing and quality control activities are conducted in compliance with current GxP guidelines.
- Assisting with service provider oversight, including qualification, routine audits and vendor quality management plans
- Providing quality assurance and compliance oversight of CMOs and CROs to ensure their products/deliverables meet all required quality standards and specifications.
- 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
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 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 amp; written communication skills.
Benefits
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 oncolog