Quality Manager - Contract - Lexington, MA
We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a dedicated Quality Manager to provide quality support for US Domestic and Global Distribution Logistics, including regions such as Puerto Rico.
Primary Responsibilities:
The successful candidate will be involved in ensuring quality in programs like the Patient Assistance Program, Access to Medicines, and Physician Sample Program. You will also be responsible for enhancing the US Customer Experience through quality assurance.
Skills & Requirements:
- Proficiency in quality management systems and enterprise software.
- Strong understanding of distribution logistics and compliance activities.
- Ability to manage supplier relationships and conduct quality audits.
- Knowledge of regulatory requirements related to drug supply chain security.
The Quality Manager's responsibilities will be:
- Support US Commercial Quality by conducting temperature evaluations, managing product returns, and approving change controls and CAPAs.
- Oversee quality approval for export-related investigations and review USGDL procedures and transport validation documents.
- Train and become proficient in enterprise systems such as TrackWise, SAP, and Veeva.
- Gain knowledge of Drug Supply Chain Security Act requirements, controlled substances, and anti-diversion measures.
- Manage US Approved Suppliers, including participating in quality business reviews and audits.
- Execute standards related to risk management, self-inspection, internal audits, and Supplier Business Reviews.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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