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Validation Lead
Join our R&D team and build the Ketryx platform
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
Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Due to Austrian law we are obliged to quote the minimum yearly gross salary of € 35,042, in accordance with the respective collective agreement (IT-KV). The salary that Ketryx offers you is adjusted to the current market situation and does significantly exceed it.