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Title

Head of Software Validation 

Position Head of Software Validation  
Full-Time/Part-Time Full-Time  
Location US - Headquarters Based in Austin Texas  
Description

L7's Enterprise Science Platform is focused on information systems and software applications in areas that include manufacturing systems, laboratory and clinical information management systems, and computerized instrumentation. Software Validation Manager will be responsible for ensuring the overall compliance for V&V testing documentation, development and execution of protocols, and strategic planning for compliant ESP implementations in a GMP environment. On a day-to-day basis, the Software Validation Manager will be hands on with the Product Management, Quality Assurance, and Implementation teams to support internal and external SDLC management.

Responsibilities:

You will be responsible for leading ESP core software regulatory compliance as well as guiding best in class implementation practices. Responsibilities include:

  • Provide interpretation, guidance, and training regarding qualification and validation requirements for GxP implementations. Participate/lead in the review of current and future SDLC/CSV policies and procedures.
  • Participate in project teams and author (as needed), review and approve computer validation related documentation. Assist with the development of system requirements and specifications to ensure requirements that are testable and end market regulatory requirements are met.
  • Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485 and ISO14971
  • Support initiatives related to audit readiness, management of internal audits and customer audits, and responding to findings in areas of responsibility.
  • Support execution of strategic roadmap by collaborating with cross functional teams to identify required software and QMS requirements.
  • Actively coach talent across the tech organization on quality principles. Partner with training to prepare user documentation and training materials.
  • Evaluate proposed changes to validated computer systems and recommend level of validation activities.
  • Act as a CSV Subject Matter Expert on customer implementations. Work with project management to include validation activities in implementation timelines
 
Position Requirements

Education and Preferred Qualifications:

  • Bachelor's degree or higher in computer science or biotechnology discipline or equivalent experience.
  • Minimum of 7-10 years related experience with CSV validation lifecycle management, validation documentation development.
  • Deep knowledge of regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).
  • Effective organization, project management, problem-solving, training/coaching, and conflict resolution and interpersonal skills and the ability to manage priorities in a time sensitive environment
  • Strong experience working with Agile/Scrum development methodology is a plus.
  • Prior experience working with regulatory on submissions of software documents to the FDA is preferred.
  • Full understanding of design control 21 CFR 820.30.
  • Strong oral and written communication skills. Strong teamwork and interpersonal skills
  • Proven ability to achieve results in a fast-paced, dynamic environment. Ability to function in a startup environment
 
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  

This position is currently not accepting applications.

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