Sr. Manager, QA GMP Trainer

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)
  3. United States
San Diego, USA
Posting date: 10 May 2021
QA.JZ.37361

*This position requires being in San Diego. Please do not apply if you are looking for a remote only position. There is some work from home flexibility, but majority of the time will be in office.*

Company currently uses VEEVA for compliance training.

Job Responsibilities:

  • Manage day-to-day overall operations of assigned clinical trial(s) with minimal need for mentor oversight. May require operational oversight of multiple trials.
  • Develop the position and assume responsibilities as Corporate Training Administrator and Trainer for GMP QA Systems.
  • Administrate and manage the training program through the electronic Learning Management System (LMS).
  • Manage, provide oversight, support and execute software validations for systems with 2-3 releases per year.
  • Participate and contribute to the corporate training steering committee.
  • Partner with company-wide departments including Human Resources, Legal, Sales, Information Technology and Finance to deliver compliance training to international sites and personnel.
  • Provide relevant metrics on a routine basis to Quality management for company-wide distribution
  • Communicate with company management on training assignments, curricula review, metrics and GxP annual training.

Skills and Requirements:

  • Bachelor's degree in relevant technical or scientific field, Chemistry, Biology, or Chemical Engineering preferred.
  • Minimum 6 years of experience working in the Biotech or Pharmaceutical Industry in Quality Assurance and/or Quality Control. Equivalent combination of education and applicable job experience may be considered.
  • Working knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.
  • Working knowledge of Veeva QMS and LMS or other comparable software
  • Experience with implementing and maintaining pharmaceutical quality systems.
  • Self-motivated with a solid sense of ownership in areas of responsibility.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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