Associate Director of Manufacturing for Leading Pharmaceutical Company
- Associate Director of Manufacturing
- Greater Washington DC area
A leading Pharmaceutical Company is seeking an experienced Associate Director of Manufacturing to help manage the licenses, material, production, and shipments.
Reporting directing to the COO, The Associate Director of Manufacturing will be supervising all DEA activities, review and maintain security controls, and coordinate progress and destruction of controlled substances. This Director will ensure all staff adhere to guidelines and all other requirements with use of cGMP regulations.
The Associate Director of Manufacturing will have the following responsibilities:
- Manage DEA activities
- Stay updated on SOPs in relation to DEA and FDA guidelines
- Ensure that cGMP guidelines are being met and exceeded
- Stay up to date with DEA regulations
- Implement LEAN Six Sigma principles throughout the facility
- Perform investigations relating to DEA affairs
- Ensure FDA, USDA, and DEA guidelines
- Direct all control substance movements
- Lead site-wide controlled substance training in compliance with LEAN Six Sigma
- Perform yearly inventory as stated by DEA and FDA
- Ensure compliance with both DEA and FDA
The ideal Associate Director of Manufacturing will have the following:
- Bachelor of Science
- 4+ years of experience within a cGMP-regulatory position
- LEAN Six Sigma manufacturing knowledge and experience
- Experience in pharmaceutical manufacturing
- Quality Assurance experience
- Excellent Organization skills
- Great Communication skills
- Ability to grow with the company
