Director, IT GxP Systems

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology 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 has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.

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.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to [email protected]

Position Summary:

The Director, IT GxP Systems will play a key leadership and contributor role in supporting and driving all GxP computerized system programs and initiatives within IDEAYA. This role will design, develop and manage all cross-functional deliverables and stakeholder commitments required to support and maintain the IT systems supporting GxP activities. This will be a critical role responsible for generating and delivering the IDEAYA IT technology roadmap, optimize and manage the computerized system qualification/validation program, assess and develop a comprehensive data integrity plan across all Clinical programs, and provide technical support across all IT systems.

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

Local candidate applications only please. Relocation assistance will not be provided for this role.

What you'll do:

• Own and manage the CSV/CSA program for all GxP IT systems, including configuration, implementation, change, and maintenance processes.
• Oversee internal support staff and external service providers to ensure appropriate GxP compliance.
• Develop and manage the portfolio of GxP IT projects. Align GxP IT technology roadmap with information security, GxP compliance requirements and enterprise IT architecture.
• Comprehensive business understanding of Quality and Regulatory functions within a life sciences organization. Beneficial to have an understanding of other functions such as Clinical Operations, Biometrics, and Drug Safety.
• Deep understanding of the necessary activities required to drive IT compliance to support GxP compliance, regulatory filing, regulatory inspection, and commercial launch.
• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV/CSA processes and clear vision for establishing a validation service to GxP stakeholders.
• Work with Functional Leadership to develop a comprehensive Data Integrity plan for internal and external GxP IT systems supporting registrational clinical programs.
• Significant experience implementing SaaS systems and other software solutions to support regulated life science business processes.
• Serve as a technical subject matter expert to the organization and customers, and mapping customer requirements to software capabilities of IT systems ensuring optimal technical implementation.
• Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based systems.
• Develop and establish departmental SOPs, qualification/validation protocols and reports with ongoing awareness to changes in business or regulatory.
• Work with business owners to formulate and conduct training sessions and teaching materials for propagating enterprise applications knowledge throughout the organization as appropriate.

Requirements:

• Bachelor’s degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience.
• Minimum 10 years direct GxP IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization and 5 years of IT leadership experience.
• Experience working in the Pharmaceutical, Biotechnology, and/or Life Sciences regulated industries.
• Experience with GxP environment, CSV/CSA, change management, and discrepancy reporting
• Experience with representing IT in partner audits / Health Authority Inspections is preferred.
• Technical mastery and knowledge of the relevant industry.
• Experience with GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
• Ability to support mission-critical business solutions.
• Track record working in a fast paced, highly iterative environment.
• Should be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must.

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office is $206,443-$226,392. 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. 

The Company complies with all laws respecting equal employment opportunity 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 at the Company’s facilities, with partial work-from-home flexibility,  and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise 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.

Benefits

Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.

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. EOE/AA/Vets.

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