Manager of Quality Systems

Job Description

As a Manager of Quality Systems, you will be responsible for oversight and management of our client’s Quality Systems and department.

Responsibilities:

• You will manage our client’s Quality Systems Program that includes: Deviations/Corrective and Preventative Actions (CAPA), Change Control, Supplier Qualification, KPI and Environmental Program.
• You will write, review and/or approve Deviations, Complaints, Quality System Standard Operating Procedures, Change Controls and Specifications.
• You will write, review and/or approve manufacturing instructions and/or batch records.
• You will be responsible for product release activities including batch record review, product disposition, returns, salvages, recalls, product improvement and product annual review.
• You will conduct/assist in investigations of deviations and CAPAs; Out of Specifications (OOS’s) for Release/Stability and Out of Trends (OOT’s).
• You will be responsible for the oversight of the training program documentation. Provide training as required.
• You will write, review and/or approve OOS, including stability OOS.

Requirements:

• You will have a Bachelor’s degree in a scientific discipline.
• You will have a minimum of five (5) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
• You will have a minimum of five (5) years of experience with Quality Assurance / Quality Control practices in a pharmaceutical environment.
• You will have an advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
• You will have excellent time management and organization skills.
• You will have strong written and verbal communication and employee relation skills.
• You will be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.