QA Manager- Pharma
Location: Florida
Work situation: On-site
A mid-size CDMO is looking for an experienced Quality Assurance Manager to join a dynamic team. The ideal candidate will have a proven track record in the pharmaceutical or consumer goods industry, specifically with OTC and liquid drug products. As a Quality Assurance Manager, you will be responsible for ensuring compliance with regulatory requirements, maintaining quality standards, and driving continuous improvement initiatives.
The QA Manager will have the following responsibilities...
- Oversee all aspects of quality assurance activities related to OTC and liquid drug products manufacturing.
- Lead investigations, deviations, and Corrective and Preventive Action (CAPA) processes to identify root causes and implement effective corrective actions.
- Develop and maintain Standard Operating Procedures (SOPs) in accordance with regulatory requirements and company policies.
- Ensure compliance with 21 CFR regulations and FDA guidelines.
- Conduct internal audits to assess compliance with quality standards and identify areas for improvement.
- Manage complaint handling processes, including investigation, resolution, and trending analysis.
- Implement and maintain change control processes to manage changes to processes, equipment, and documentation.
- Develop and deliver training programs for employees on quality systems, regulations, and procedures.
- Lead supplier qualification activities to ensure the selection of qualified suppliers and vendors.
- Collaborate with cross-functional teams to drive quality and continuous improvement initiatives.
The QA Manager should meet the following requirements...
- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance roles within the pharmaceutical industry, with specific experience in OTC and liquid drug products.
- Thorough understanding of investigations, deviations, CAPAs, SOPs, and change control processes.
- Strong knowledge of 21 CFR regulations and FDA guidelines.
- Experience in conducting internal audits and managing regulatory inspections.
- Certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus.
Benefits:
- 401k Matching Program
- Dental, Vision and Medical Insurance
- Competitive Salary
- Relocation assistance
