Biologics Quality Assurance Senior Manager

Education

Required: Bachelor's degree in a related field.  

Preferred: Master's degree in a related field. 

Experience

Required: Eight years of relevant experience to include four years of supervisory or managerial experience. With Master's degree, five years of required experience to include four years of lead or supervisory experience. 

Preferred:

• 10+ years in a quality role in the biopharmaceutical industry with a minimum of 5 years in a QA managerial role.

• Strong demonstrated knowledge of cGMP/cGTP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.

• Demonstrated experience leading qualification and validation of facilities, process and systems.

• Experience working with cell therapy or biological products.

• Experience with initiation of Quality systems including establishing and maintaining supplier qualification program.

• Strong problem solving, risk identification, assessment, evaluation, impact analysis abilities and ability to execute efficient and effective mitigations.

• Strong scientific competence and ability to critically assess technical and compliance risks.

• Demonstrated ability to work as a team player with multi-disciplinary project teams.

• Excellent attention to detail with an ability to perform critical review of various types of documents.

• Must be able to multitask in a fast-paced environment and make balanced decisions related to prioritizing quality as required for manufacturing needs.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html