Senior Quality Assurance Manager

HIRING: Manager/Senior Manager, QA - Growing Biotech Company - Maryland
Hays Life Sciences is exclusively partnered with a growing biotechnology company to assist in their search for a Manager/Senior Manager, Quality Assurance to be based in Maryland. They are working to advance a promising product pipeline across multiple therapeutic areas, which has led to multiple partnerships with leading pharmaceutical companies globally. They have a new manufacturing layout across their two sites in Maryland which has resulted in a need to grow their staff. The Manager/Sr. Manager, QA will be an important addition to the team, responsible for people management as well as hands-on individual contributions.

In this capacity, you will be responsible for managing QA activities relating to drug product and clinical trial material release. You will review fill finish, packaging, and labeling batch records, manage deviation investigations, change controls, non-conforming events and manage relationships with contract manufacturing organizations (CMO’s). You will conduct external audits of CMO’s to ensure compliance with FDA and EU regulations. Travel in this position is approximately 20% (domestic and international).

At minimum, you must possess a Bachelor’s degree with 5+ years of QA pharmaceutical/biotechnology industry experience in GMP regulated commercial environment, people management experience, and drug product experience. External auditing experience and CMO management experience is also required.

Apply now for consideration.


Job type:
Full Time
Competitive / Based on Experience
Apply Now

Talk to a consultant

Talk to Phu Huynh, the specialist consultant managing this position, located in New York

23rd Floor, 555 Eighth Avenue, New York, NY, United States of America, 10018-4378

Telephone: 212 548 4525

Share Job