Associate Director, Clinical QA
Alkermes · Waltham, Massachusetts, United States · $167K–$182K/yr
Biotechnology Research · 1,001-5,000 employees
About the role
Provides oversight and conducts clinical site, vendor, and internal system audits to ensure compliance with cGCP and GLP. Leads CQA projects, manages department resources, and identifies critical business and compliance risks.
What they look for
Requirements
Requires a degree in Nursing, Health Science, or a related field with 10+ years of auditing and compliance experience. Must possess working knowledge of ICH GCP regulations and experience with clinical trial management systems.
Benefits
Full description
This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCP and GLP. This person supports the department initiatives by leading CQA projects and assists with management of department resources.
This position must be able to quickly identify critical and high-risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues.
In addition to a travel requirement of ~40%, this person will also need to be onsite and local to our Waltham, MA office 3x a week.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
