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Validation Lead

Join our R&D team and build the Ketryx platform

Engineering & Data
Vienna or Boston
Remote
About Us

Ketryx is making software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. Our developer-first approach ensures safety and reliability is ingrained into healthcare products from the ground up, leading to increased developer productivity, patient satisfaction, revenue growth, and cost savings.

Job Description

This is a full-time leadership role with remote options for a validation expert with a biopharmaceutical background in validation. While providing computer systems validation support for Ketryx to ensure quality and compliance, you will also lead the computer validation/qualification activities and use your technical knowledge, interpretation, and direction to comply with industry and regulatory requirements. The lead job includes customer interaction as you help clients on their compliance journey as well. The validation lead will work closely with the CEO, VP RA/QA, and CTO on a daily basis. Location: Boston or Vienna, Austria-preferred.

About You
  • You have at least 5 years of experience in computerized software validation (CSV) in a GMP environment

  • You have experience with GMP cloud-based applications and/or software infrastructure compliance

  • You enjoy working in a fast paced, ever-changing environment

  • You have strong leadership skills

  • You have a background in biopharma/biotech (a plus)

  • You have effective verbal, written communication, presentation skills with diverse audiences

  • You have former software development, QA, and automation experience (a plus)

  • You have a familiarity with the regulated product development process and FDA regulations (a plus)

  • You have a Bachelor’s degree in Engineering/Sciences or equivalent relevant technical experience

  • You have knowledge of Agile software development and software testing methodologies (a plus)

  • You have excellent written and oral communication skills, good decision-making skills, and time management skills

  • You are comfortable speaking with clients

  • Boston Area or Vienna, Austria-local preferred; remote possible

About the Role
  • Lead and execute (as needed) the validation activities for Ketryx’s general releases and hotfixes, as well as periodic product revalidation

  • Responsible for tracking, monitoring, and controlling the validation process

  • Ensure timely delivery to meet pre-scheduled release dates and budgets

  • Provide technical expertise, regulatory interpretation, and direction in regards to computer validation, federal regulations, and other quality system requirements

  • Effectively work with cross-functional teams (Product Management, Customer Success, and Developers) to ensure the validated state of the system is maintained

  • Ensure requirements are adequately tested following a risk-based approach

  • Identify and log issues found during validation execution. Work closely with Ketryx’s teams to identify and prioritize issues early on and track validation incidents to closure

  • Ensure clear traceability against all testing performed

  • Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices

  • Independent pre and post-execution review of validation test scripts

  • Coordinates with cross-functional teams to design and execute test protocols

  • Supports change control as validation technical resource and ensures timely completion of required tasks

  • Perform validation impact analysis and risk assessments in conjunction with product teams

  • Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems

What We Offer
  • Competitive salary and generous stock options

  • Work in an exciting field with a positive impact on the world

  • Flexible working hours

  • Remote work options

  • Offices in Vienna and Boston

  • Generous PTO

  • Opportunity to learn and grow as part of a global team

Apply for this Role
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