Director, IT Computer System Validation & Quality Assurance at Eikon Therapeutics

Millbrae, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Skills

Key technologies and capabilities for this role

Computer System ValidationQuality AssuranceBiotechnologyPharmaceutical IndustryRegulatory RequirementsFDAGxPValidation DocumentationAnalytical SkillsProblem-SolvingLeadershipCommunication

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in the Millbrae, CA office to ensure effective management, operational excellence, and collaboration.

What are the key required skills and experience for this position?

The role requires experience in computer system validation and quality assurance within biotech or pharmaceutical industry, in-depth knowledge of FDA and GxP regulations, proficiency in writing validation documentation, exceptional analytical and problem-solving skills, and strong leadership and communication skills.

What is the salary or compensation for this role?

This information is not specified in the job description.

What leadership responsibilities does this role involve?

The Director will provide leadership and direction to the Software Quality Assurance team, fostering a culture of quality excellence, and lead the global strategy for CSV and software QA.

What makes a strong candidate for this Director position?

A strong candidate has biotech/pharma experience in CSV and QA, deep regulatory knowledge of FDA/GxP, proficiency in validation documentation, and proven leadership skills to guide teams and ensure compliance.

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