Associate Director - IT Computer Systems Validation & Assurance (CSV)

Employer
Recursion
Location
Salt Lake City, Utah, United States
Posted
Nov 28, 2021
Ref
3615680
Required Education
Bachelors Degree
Position Type
Full time

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life.

The Impact You’ll Make

  • Partner with stakeholders to develop the vision and associated controls including policies necessary to guide the implementation, maintenance and compliance of a CSV program that ensures business risks are managed.
  • Provide expertise and support regarding best practices, process development/improvement and risk management for computer systems in the organization.
  • Determine the appropriate level of qualification and validation necessary for computing systems to ensure holistic risk management balancing regulatory and compliance needs with business risks.
  • Maintain expertise in current and emerging cGMP requirements, quality trends and IT technology trends that influence CSV including CSA (Computer Systems Assurance).
  • Implement risk-based computer systems validation activities (e.g., specifications, testing, qualification, and implementation). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.
  • Coordinate all aspects of computer systems validation activities, including project plans, validation strategies, document development, document reviews and approvals.
  • Review vendor generated validation documentation to determine suitability and alignment with company CSV SOPs and GAMP 5.
  • Lead the implementation, modification and practice of Computer System Validation Standard Operating Procedures (SOP) and Information Technology (IT) GxP procedures based on current regulations and industry standards.
  • Ensure appropriate remediation plans are identified for gaps identified during the periodic reviews.
  • Be an expert for CSV during regulatory inspections.
  • Collaborate with business quality to monitor audit observations related to GxP computerized system and computer system validation to ensure gaps are identified and adequately addressed.
  • Conduct ongoing periodic assessments or audits of third party vendors.

The Team You'll Join

You will be joining a growing IT and Information Security team at Recursion,focused on enabling Recursion to decode biology by providing world class technology services that are designed and fit for purpose. You'll collaborate with your teammates and across departments to agree on what the most important challenges and capabilities are, then figure out how to get us there.

The Experience You'll Need

  • 6+ years in the IT CSV space and 3+ years in a broad global leadership/management role in a highly regulated environment
  • Knowledge of Global Pharmaceuticals Supply Chain, Manufacturing, and Quality operations
  • Knowledge of 21CFR Part 11, current GxP (e.g. Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, etc.) Computer System Validation, regulatory requirements and GAMP 5 for a global operation
  • Experience in writing, reviewing, and executing computer validation documentation including Risk Evaluation, Risk Assessment, VMP, IQ, OQ, PQ, TM)
  • Experience with the principles of computer systems validation, GxP, risk-based approach, assurance and testing best practices
  • Understand existing and new business processes and requirements, to ensure validation of systems
  • Experience with SaaS and Cloud systems in a GxP environment required
  • A deep understanding of drug development processes from discovery through development manufacturing and post-marketing, with an ability to understand business requirements and translate them into practical solutions
  • Manage risks in a way and manner that achieves business objectives and reduces business risks broadly

#LI-BW1

The Benefits/Perks You’ll Enjoy as a Full-Time Employee at Recursion: 

  • 100% Coverage of health, vision, and dental insurance premiums 
  • 401(k) with generous matching (immediate vesting)
  • Stock option, restricted stock unit (RSUs) and employee stock purchase plan (ESPP) programs
  • Two one-week paid company closures (summer and winter) 
  • Flexible vacation/sick leave
  • Generous paid parental leave (including adoptive)
  • Onsite daycare facility** (Salt Lake City)
  • Commuter benefit and vehicle parking to ease your commute** 
  • Complimentary chef-prepared lunches and well-stocked snack bars** (Salt Lake City)
  • Monthly fitness/wellness stipend 
  • One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking** (Salt Lake City)

**United States based employees

More About Us 

Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City. 

Learn more at www.recursion.com, or connect on Twitter and LinkedIn.

Recursion is an Equal Opportunity Employer that values diversity and inclusion.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.