Quality Assurance Director

Our client is a growing organization in the Greater DC area. This is a confidential search and more will be discussed upon interviewing!

Our client offers excellent benefits, retirement, bonus, and PTO! More will be discussed upon application! This is a confidential search.

There will be a more detailed JD provided

Management Responsibility
cGMP compliance for the overall site
Training program for the entire site.
Assigning Job functions to all direct reports and ensure to meet the organization expectations.
Monitor Statistical Reports and prepare trend report analysis.


Knowledge & Skills

• Excellent written and oral communication skills, sound decision-making based on experience, good supervisory skills including the ability to delegate effectively, good people-skills including the ability to coach and teach subordinates.
• Leadership development- supervision, management, and training
• Ensure all activities are in accordance with cGMP’s and SOPs
• Serve as company’s representative/host for regulatory audits and inspections (Primarily USFDA)
• Liaise with clients to ensure good relationships
• Prepare/review/ approve external and internal reports and propose and manage QA department budget

Experience & Education

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• At least 10 years of experience in a quality assurance role in a cGMP-regulated environment.
• Strong Knowledge of GMPs (21 CFR 210/211, ICH Q7)
• Experience in Regulatory interface/Inspections (e.g. FDA, EU)