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Well known Pharmaceutical Company is seeking a Quality Assurance Manager. The Quality Assurance Manager is responsible for working with many groups in the Company and with FDA.
Responsibilities include:
· Assemble and review data and information required for drug release.
· Work closely with all relevant departments to ensure availability of proper documents for timely release of finished product.
· Effectively communicate with FDA personnel in order to resolve issues and ensure effective inspections.
· Participate in formulation of submissions and approval strategies for projects in the department.
· Communicate with consultants, attorneys, and customers as needed to ensure proper understanding of product status and relevant FDA requirements.
· Ensure compliance in all areas and activities including manufacturing, controls, and labeling.
· Lead or participate in various task force activities related to new applications and supplements.
Qualifications:
Bachelor's or Master’s degree in a scientific or technical discipline with 5-10 years experience is required.
Previous experience in Quality Assurance required.
Strong interpersonal skills and ability to effectively interact with FDA and company personnel at all levels required.
Excellent technical writing and strong verbal communication skills are a must.
- Location: Baltimore
- Compensation: Based on experience
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.