- Exciting leadership position within QA with high visibility
- Join commercial stage Biotech company with diverse product portfolio
About Our Client
Our client is a rapidly growing commerical biotech company focused on th development and manufacturing of opthalmic baseed therapies.
- Lead the Quality team supporting Analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports.
- Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations.
- Ensures quality staff assesses and approves change controls
- Ensure regulatory submissions align with filing strategy. Review and approve submission amendments.
- Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelors degree in Life Sciences discipline + minimum of 10 years Quality Assurance experience within the life sciences markets
- Must have direct experience managing Quality Operations
- Previous management experience required
- Must have significant knowledge of GxP and QA principles, practices, and standards
What's on Offer
- Very competitive benefits package and salary with potential bonus opportunity
- Flexibility of a start-up environment at established commerical company
- Career growth and development
- Work on a diverse product portfolio with high energy and passionate team