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Title

Audit Manager 

Position Audit Manager  
Full-Time/Part-Time Full-Time  
Location US - Headquarters Based in Austin Texas  
Description

Job Purpose:

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. Audit Manager will be responsible for hosting external audits, performing internal audits, and assisting in QMS activities as needed.

Responsibilities:

You will be responsible for leading company audits while working with Quality Compliance Manager to ensure ESP core software regulatory compliance.

Responsibilities include:

  • Manage and ensure timely performance of internal audits, external audits, responses to findings, and remediation activities.
  • Ensure timely creation and closure of deviations, change controls, and corrective and preventive actions (CAPAs) associated with internal and external audits.
  • Optimize external audit process to follow L7 audit approach (External Audit Guide, Audit Agenda Template, Internal Guide for External Audits and Links, etc.).
  • Provide internal guidance on standard operational procedure updates to meet regulations and to achieve targeted certifications.
  • Assist with authoring and updating standard operating procedures.
  • Educate talent across the tech organization on audit readiness techniques.
  • Actively coach talent across the tech organization on quality principles. Partner with training to prepare user documentation and training materials.
  • Support execution of strategic roadmap by collaborating with cross functional teams to support required software and QMS requirements.
  • Assist Quality Assurance Management with other special projects as needed.
 
Position Requirements

Education and Preferred Qualifications:

  • Bachelor's degree or higher in computer science or biotechnology discipline or equivalent experience.
  • Minimum 5-7 years related experience working with quality management systems and audits.
  • Minimum of 7-10 years related experience working in regulatory environment.
  • Knowledge of regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).
  • Experience in ISO certification is a plus.
  • Proven leadership skills, with the ability to develop and motivate teams.
  • Strong analytical, negotiating, and technical skills. Has the ability to handle conflict from varying parties
  • Effective organization, project management, and the ability to manage priorities in a time sensitive environment
  • Prior experience working with Laboratory Information Management Systems is preferred
  • 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 a plus.
  • 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 accepting applications.

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