Quality Manager - Permanent - Birmingham, AL
Are you passionate about quality and precision? Join our client as Quality Manager and help ensure top-tier standards every day. Proclinical is on the hunt for a Quality Manager to be responsible for overseeing and maintaining the company's QA and QC programs.
Primary Responsibilities :
This role ensures full compliance with FDA cGMP, ICH Guidelines, DEA regulations, and other applicable industry standards. The Quality Manager leads the Quality Department, supporting a growing portfolio of pharmaceutical products and driving continuous improvement across all quality systems and processes.
Skills & Requirements :
- Bachelor's degree in a scientific or technical discipline.
- 3+ years of Quality Management or QA experience in pharmaceuticals or related manufacturing.
- Strong understanding of FDA cGMP, 21 CFR 210 / 211, and quality systems.
- Experience with audits, CAPA, and supplier oversight.
- Excellent communication, organization, and leadership skills.
The Quality Manager's responsibilities will be :
Ensure compliance with FDA 21 CFR 210 / 211 and cGMP requirements.Manage QA / QC programs including product release, document control, deviations, CAPA, and training.Lead internal audits, regulatory inspections, and follow-up actions.Oversee supplier qualification and product testing with third-party labs.Support continuous improvement, root cause analysis, and risk management.Review and approve batch records, CoAs, and specifications.Mentor and guide quality staff.Compensation :
$75,000 to $85,000 per annum.