About this role

Responsible for execution and performance of Lantheus CQA quality system elements.
Serve as the CQA lead for assigned trials ensuring timely communication of quality risk and compliance.
Development and execution of a risk-based clinical quality audit plan.
Audit internal processes, clinical investigator sites, and vendors.
Analyze and trend audit observations to support continuous improvement.
Author audit reports and coordinate supporting documentation.
Identify non-compliance trends and systematic risks.
Support the conduct of mock inspections and related activities.

Bachelor’s degree in a scientific discipline preferred.
Minimum 7 years’ experience in the pharmaceutical or biotech industry.
Five (5) or more years in GCP Clinical Quality Assurance.
Proficient understanding of ICH GCP and applicable CFR regulations.
Experience providing GCP Clinical Quality Assurance guidance to Clinical teams.
Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
Experience in conducting internal and external GCP audits and authoring audit reports.
Analytical and critical thinking skills.
Excellent communication (Oral and Written) skills.
Experience leading regulatory inspection readiness/preparation activities is a plus.

Comprehensive health benefits package including medical, prescription drug, dental, and vision coverage.
Life and disability benefits.
Pre-tax accounts.
401(k) with company contribution.
Paid vacation, holidays, sick days, and paid parental leave.

Associate Director – Lead GCP Clinical Quality Assurance

Key skills