Director, IT Computer System Validation & Quality Assurance

Millbrae, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

Candidates should possess a postgraduate degree with over 10 years of experience or a bachelor's degree with over 12 years of experience in computer system validation and quality assurance within the biotech or pharmaceutical industry. In-depth knowledge of regulatory requirements such as FDA and GxP pertaining to computer system validation and quality assurance is essential, along with proficiency in writing validation documentation and strong analytical, problem-solving, leadership, and communication skills.

Responsibilities

The Director, IT Computer System Validation & Quality Assurance will define and drive the global strategy for CSV and software QA, establish governance for validation lifecycle management, and collaborate with IT, Clinical, and Regulatory teams. They will own and evolve the organization's CSV framework, ensure validation activities meet regulatory and business requirements for systems like Veeva Vaults, QMS, Safety systems, and custom applications, and develop/execute strategies for computer system validation. Responsibilities also include establishing and maintaining validation protocols, providing leadership to the Software Quality Assurance team, creating/reviewing/maintaining documentation, preparing validation reports for submissions, designing/overseeing test case execution, identifying deviations, optimizing processes, developing training programs, staying current with regulations, and ensuring audit readiness.

Skills

Computer System Validation

Quality Assurance

Biotechnology

Pharmaceutical Industry

Regulatory Requirements

FDA

GxP

Validation Documentation

Analytical Skills

Problem-Solving

Leadership

Communication

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees