Associate Director, Clinical QA

Alkermes • Waltham, MA

2d • $166,850 - $181,564 • Hybrid

About The Position

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.

Requirements

• Must be able to quickly identify critical and high-risk business and compliance issues and report immediately to CQA management.
• Must be able to assist/lead investigations and/or corrections of critical and high-risk business and compliance issues.
• Requires ~40% travel.
• Must be onsite and local to our Waltham, MA office 3x a week.

Responsibilities

• 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.
• Supports department initiatives by leading CQA projects.
• Assists with management of department resources.
• Quickly identify critical and high-risk business and compliance issues and report immediately to CQA management.
• Assist/lead investigations and/or corrections of critical and high-risk business and compliance issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed