Sr. Manager/Manager, QA Documentation

Position Summary

Reporting to the Director of GMP Quality Assurance Operations, this position will responsible for management of Quality documents and records, administering Veeva electronic document management system, conducting Quality checks on QA and other critical department records as required, managing the training program, developing compliant Quality documentation systems and procedures as needed, and building the QAD staff as needed. This is a full-time position located in Cambridge MA.

Responsibilities
  • The position will be responsible for the following functions:
    • Document Controller: Manage/control QA other departmental documents and records as needed
    • QA Document Reviewer: Will perform quality reviews of QA, CMO, CTO Research & Tech Ops documents & records (including GMP batch record review) as needed
    • Veeva Support: Support IT Veeva administrator, author procedures, train GxP personnel and manage document lifecycles
    • Training Coordinator: Manage training program and individual training folders, including SOP, form and template creation; support implementation of electronic Learning Management Systems.
Minimum Qualifications
  • The successful candidate will have a minimum of 10 years’ experience in related QAD role
  • Additional experience in QA and/or Quality System improvement roles is preferred
  • A BA or BS is preferred though long-time experience in QA may be acceptable
  • Strong organizational skills and attention to detail are required
  • Strong interpersonal skills are required
  • Computer skills and previous experience with eQMS systems is required
Preferred Qualifications
  • Experience with Gene Therapy/Cell Therapy products
Competencies
  • Collaborative Openness, One Team
  • Undaunted – Fearless, Can-do attitude
  • Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  • Entrepreneurial Spirit – Proactive. Ownership mindset.

Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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Requisition # 2018-367

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