Director It Computer System Validation And Quality Assurance (Csv - Qa)

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

The Director, Computer System Validation and Quality Assurance (CSV-QA) will be responsible for the strategy and implementation of IT ComputerSystem Validation and Quality Assurance program for GxP regulated IT systems. This individual will oversee the Validation and continued compliance of the IT systems and processes. Additionally, this individual will be responsible for the IT GxP Training program.

About You

You develop and implement the CSV-QA strategy. You successfully manage Validation and continued compliance of multiple GxP IT systems. You have excellent CSV skills. You are self-motivated, organized, and detail oriented. You possess excellent interpersonal and communication skills. You collaborate across diverse disciplines. You thrive in a fast-paced environment.

What You’ll Do

• Responsible for the development of Computer System Validation and Quality Assurance strategy for IT systems supporting GxP business processes throughout the complete system lifecycle.
• Collaborate with the Corporate/Clinical Quality Assurance in the development, implementation and execution of CSV process and procedures.
• Responsible for the development of Standard Operating Procedures and Work Instructions for complete system lifecycle including Risk Management, Computer System Validation and Change Control.
• Partner with System/Process Owners to implement and maintain GxP computerized systems in a validated state and in accordance with regulatory agency regulations and internal requirements.
• Manage and oversee validation of IT GxP systems.
• Manage the change control process across all the IT GxP systems.
• Collaborate with Corporate/Clinical QA for IT system vendor audit and qualification.
• Represent IT during internal and external agency audits and inspections.
• Develop IT CSV-QA Training program and manage compliance of the training program for applicable IT team members.

Qualifications

• Bachelor’s degree in engineering, Information Systems, Computer Science or equivalent with a combination of education/work experience.
• 12+ years of experience in developing and implementing Computer System Validation, data integrity and Quality practices. Experience with Computer System Validation across Clinical Operations, Data Management, and ERP systems.
• Excellent understanding of the CFR Part 11 and Annex 11 regulations for Computer Systems.
• Collaborative skills in working with a wide range of users including Corporate Quality Assurance to develop Computer System Validation program.
• Experience with educating and training users at different levels on the Computer System Validation process and practices.
• Experience with planning and scheduling timely completion of System Validation projects.
• Self-starter with the ability to act and operate independently.
• Natural curiosity to take on new challenges, responsibilities, and gain business knowledge.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

The expected salary range for this role is $189,000 to $217,000, depending on skills, competency and the market demand for your expertise.