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Director, Data Integrity QA
at TrialSpark
New York; Remote
About TrialSpark
On a mission to bring new treatments to patients faster and more efficiently
Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data.
The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark’s current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.
About the Position
This person will report to the Director of Quality Assurance. They will be stewards of TrialSpark’s Data Integrity and Computer Systems Validation programs, and responsible for the company’s policies, procedures, and trainings within them. They will work closely with the Engineering, Product, TechOps, and Biometrics teams to ensure system compliance, lead deviation management, and provide audit support.
Responsibilities
- Provides oversight and strategic leadership of TrialSpark’s CSV and Data Integrity programs to ensure compliance with regulations
- Partner closely with Engineering, Biometrics, Product, and TechOps groups to continually evolve the CSV and DI programs in a fit-for-purpose manner as our business and system needs change
- Drive the planning, implementation, and administration of CSV and DI related initiatives
- Establish TrialSpark’s quality culture specifically for CSV and DI
- Serve as CSV and DI representative for audits and regulatory inspections
- Conduct audits, both internal and external
- Provide support for deviation management and CAPAs as related to CSV and DI incidents
About You
- You have a degree in Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field
- You have at least 10-15 years of relevant experience in software validation and change management in the pharmaceutical industry and quality organization.
- You have a deep understanding of GXP and SDLC regulations, including 21 CFR Part 11, computer systems validation requirements (including 2023 guidances) and good documentation practices.
- You have demonstrated strong project management skills and enjoy working collaboratively with software development teams.
- You are a strong written and verbal communicator
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $193,000 – $250,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits learn more about them and our compensation philosophy here.
If this range doesn’t match your expectations, please still apply because we may have something else for you.