This position will :
Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to:
Audits of clinical vendors, clinical sites and clinical documents that will be submitted to regulatory authorities
Audits of clinical drug safety activities internally and externally/ vendors
Internal and external clinical development and drug safety systems
Work with contract auditors and CQA management to develop study specific audit plans
Review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices
Oversee and/or Conduct other GCP/GLP related audits as indicated
Collaborate with the appropriate Clinical Development team in preparation and follow-up to clinical site audits to ensure resolution of audit findings.
Plan and conduct GLP, GCP clinical vendor audits
When indicated collaborate with Clinical Development in a lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
Consult with Clinical Development and Drug Safety regarding GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
Provide review of follow-up corrective action of contracted vendor services
Support the creation, implementation and closure of assigned Change Controls
When indicated perform or supervise remote vendor audits and provide follow-up as indicated
Maintain the tracking system for all GCP/GLP audit activity and provide periodic metrics
When requested provide global GCP/GLP training for clinical investigator meetings
Assist management in the preparation and conduct of regulatory agency inspections
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.