Senior QA Manager - REMOTE
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Proclinical is seeking a remote Senior QA Manager for a global pharmaceutical company. This position reports to Director, Quality Assurance GMP.
Must be eligible to work in the US.
- Primary Quality contact for assigned external vendors supporting Clinical Program(s). Ensure appropriate Qualification of vendors and monitor ongoing compliance of operations.
- Oversight of the external activities associated with manufacturing, disposition, and distribution of clinical materials.
- Monitor performance of vendors to evaluate and mitigate program and compliance risk(s) and escalating quality issues as needed.
- Execute Forma lot disposition activities (including working with Qualified Person) to ensure that materials are released in accordance with regulatory requirements, cGMPs and policies and procedures and within project lead times.
Skills and Requirements:
- BS Degree in Chemistry, Pharmacy, Biology or a related life science or a combination of a BS Degree with relevant Quality and Technical experience
- Minimum of 7+ years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations
- Knowledge and experience of clinical and commercial systems supporting compliance with US and global GMP regulations
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at +(1) 267-297-3257 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.