Quality Assurance Operations Manager

Company: Jobot
Location: Indianapolis
Posted on: January 16, 2022

Job Description:

Rapidly growing CDMO seeks an experienced Quality Assurance Operations manager with sterile manufacturing experience

This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $100,000 - $130,000 per year

A bit about us:

Our client is a rapidly growing CDMO dedicated to the development and production of novel gene therapy products

Why join us?

Rapidly growing startup culture
Ability to "make it your own"
3 weeks vacation in addition to 1 week paid sick leave
Relocation assistance available
Annual Bonus structure

Job Details

Responsible for ensuring GMP compliance and adherence to SOPs for all operations, as well as implementation of the Quality systems including but not limited to Risk Management, Root Cause Analysis, Corrective And Preventive Actions (CAPAs), and Change Controls. Also reviews and approves all Quality Events for the site, including Out of Specification Investigations. The Quality Operations team approves Master Batch Records and label, product, and raw material specifications. This position requires advanced understanding of site processes to write and review technical documents including engineering studies, validation protocols, stability protocols, and leads and approves Internal Audits for the site.

EDUCATION / CERTIFICATIONS / LICENSES
BS in life science or related field
Knowledge in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials
Familiarity of eQMS systems such as Veeva
Experience with regulatory agency inspections

ON-THE-JOB EXPERIENCE
10+ years of experience Quality Professional in Pharmaceutical and/ or Biological Manufacturing
5+ years of experience Quality Management
Experience with Phase I/II IND clinical trials

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Keywords: Jobot, Indianapolis , Quality Assurance Operations Manager, Executive , Indianapolis, Indiana