Associate Director Of Qa

Simtrabps

Bloomington, United States
**
Leadership for filling and finishing quality operations
Ensure compliance to cgmp
Support qa oversight of aseptic filling
** Simtra BioPharma Solutions is seeking an Associate Director of Quality Assurance to lead Filling and Finishing Quality Line Operations in Bloomington, Indiana. The ideal candidate will have extensive experience in pharmaceutical manufacturing and quality operations, with strong leadership skills to ensure compliance with industry standards. **

Job Summary

  • The Associate Director of Quality Assurance provides leadership and direction for Filling Quality Line Operations and Finishing Quality Line Operations, ensuring compliance to all standard operating procedures.
  • Responsibilities include interviewing, hiring, coaching, and developing staff, as well as developing the department's annual budget and ensuring spending within expected forecasts.
  • The role requires a Bachelor's degree in a Life Science field, 12 years of pharmaceutical manufacturing experience, and a minimum of 10 years in a management role, with in-depth knowledge of FDA Annex One requirements.

Matching Summary

Match Score: 75

** Simtra BioPharma Solutions is seeking an Associate Director of Quality Assurance to lead Filling and Finishing Quality Line Operations in Bloomington, Indiana. The ideal candidate will have extensive experience in pharmaceutical manufacturing and quality operations, with strong leadership skills to ensure compliance with industry standards. **

Skills & Requirements

Must-have

  • Leadership for Filling and Finishing Quality Operations
  • Ensure compliance to cGMP
  • Support QA oversight of Aseptic Filling
  • Review and Approve deviations
  • Manage department budget and spending
  • Drive continuous improvement projects

Nice-to-have

  • Growth mindset and teamwork
  • Focus on patient health impact
  • Positive interactions with personnel
  • Empower team members for results

Key Requirements

  • Bachelor's degree in Life Science field
  • 12 years pharmaceutical manufacturing experience
  • 10 years management experience
  • In-depth knowledge of FDA Annex One

Work Rights

Not specified

Tailored Resume

Cover Letter