Base: $135,000 to $149,000; bonus: eligible for an...
Hybrid
8+ years clinical auditing experience
Gcp and gvp compliance knowledge
Clinical site and vendor audit execution
Alkermes is seeking a Manager of Clinical Quality Assurance to oversee auditing services for their Clinical Programs, ensuring compliance with Good Clinical Practices (GCP). The role requires strong leadership in managing audits and corrective actions, while collaborating with internal teams. Candidates should have significant experience in clinical auditing, with a bachelor's degree in a relevant field
Job Summary
The Manager position is an integral part of the CQA team providing oversight for auditing services in support of Alkermes Clinical Programs.
This role requires the ability to quickly identify critical business and compliance issues and lead investigations or corrections immediately.
The position offers a competitive base salary ranging from $135,000 to $149,000 with eligibility for an annual performance pay bonus.
Matching Summary
Match Score: 85
Alkermes is seeking a Manager of Clinical Quality Assurance to oversee auditing services for their Clinical Programs, ensuring compliance with Good Clinical Practices (GCP). The role requires strong leadership in managing audits and corrective actions, while collaborating with internal teams. Candidates should have significant experience in clinical auditing, with a bachelor's degree in a relevant field.
Salary
Base: $135,000 to $149,000; Bonus: Eligible for annual performance pay bonus; Benefits: Competitive benefits package offered
Skills & Requirements
Must-have
8+ years clinical auditing experience
GCP and GVP compliance knowledge
Clinical site and vendor audit execution
CAPA development and root cause analysis
ICH GCP regulation expertise
Experience with TrackWise or Veeva systems
Nice-to-have
Strong interpersonal communication skills
Ability to work under pressure
Cross-functional collaboration abilities
Remote vendor audit supervision
Continuous improvement mindset
Training delivery for investigator meetings
Key Requirements
Bachelor's degree in Nursing or Health Science
8+ years of clinical auditing and compliance experience
Working knowledge of US and International ICH GCP regulations
Proficiency with clinical trial management systems like ARISg or IMPACT