Validation Project Manager - Clinical

Our Company

 

At 2,000 employees and growing, and consistently strong financials (NYSE:VEEV), Veeva was named among the top fastest growing public technology companies on Forbesannual Fast Tech 25 list. We build innovative cloud solutions for some of the worlds largest pharmas and biotechs, and we need great people like you to make it happen.

 

Our Culture & People

 

Our core values are Employee Success, Customer Success, and Speed. We are innovators, collaborators, and thought leaders out to create best-in-class solutions that help our customers improve and extend human life. Its genuine, straight-forward, and no fuss.

 

Job Summary

 

The Validation Lead provides Computer Systems Validation support to the Quality and Compliance function in support of Veevas clinical products. Primarily responsible for supporting the ongoing validation activities across the clinical product lines, general releases and patches/hot fixes. Interaction with internal customers will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines. Drive the computer validation/qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (Business/Functional Requirements, Risk Assessments, IQ, OQ, PQ) to completion. Provide technical validation expertise, interpretation and direction to assure compliance with regulatory requirements, company policies and standards

 

Responsibilities

  • Lead and execute (as needed) the validation activities for Veevas general releases, hot-fixes, product re-baselines for Clinical applications.
  • Responsible for tracking, monitoring and controlling validation process
  • to ensure timely delivery to meet pre-scheduled release dates.
  • Provide technical expertise, interpretation and direction in regards to computer validation, GCP regulations and other quality requirements.
  • Work with Product Managers to ensure requirements/specifications are defined in a clear, compliant, testable format.
  • Effectively work with cross functional teams (Product Management, SQA, Technical Operations) to ensure the validated state of the system is maintained.
  • Identify and log issues found during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and track validation incidents to closure.
  • 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 Veevas product line and internal business systems.

 

Requirements

  • Bachelors degree in Engineering/ Sciences or equivalent relevant experience
  • 7+ years experience in regulated life science validation role.
  • Hands-on experience with the validation of clinical applications in the Life Sciences such as EDC, CTMS, eTMF, TMS, AERS and/or IVRS.
  • Solid understanding of 21 CFR Part 11, GCPs and principles of computer validation.
  • Knowledge of Agile software development, and software testing methodologies.
  • Excellent written and oral communication skill, good decision making skills and time management skills.

 

Nice to Have

  • Experience with cloud based applications and/or infrastructure compliance
  • Working knowledge of GAMP 5, ICH E6.

 

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

 


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