Director of GMP Quality Operations - Biotechnology
Michael Page

Job Info

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.

*Description*
* 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. Also including laboratory release testing review.
* 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.
* Ensures raw material risk assessments are performed per USP/ATMP guidance
* Responsible clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
* Oversight of Aseptic processing, environmental monitoring program, technical transfers between development/GMP and site/site oversight including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations

* Bachelors degree in Life Sciences discipline + minimum of 10 years Quality Assurance experience within the life sciences markets - i.e. biotechnology, pharmaceuticals.
* Must have direct experience managing Quality Operations in biologics or gene/cell therapy manufacturing
* Previous management experience required
* Quality Assurance experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility required
* Must have significant knowledge of GxP and QA principles, practices, and standards
* Ability to work in a fast-paced, dynamic, start-up environment
Our latest client is a rapidly growing, global biopharmaceuticals company based in the Boston area. This company has doubled its size and revenue in a short time, holds a robust pipeline, and has a very promising future.
* Excellent base salary
* Significant equity offered
* Bonus opportunity
* Growth trajectory with opportunity to build team in the new year
* Very competitive benefits package
* Key leadership position with decisions to influence internal and external stakeholders
* Flexibility of a start-up environment
* Major play in biotech industry
* Strong innovative culture and atmosphere