Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents.
Interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP.
Development and execution of a risk-based clinical quality audit plan for assigned programs.
Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data as needed.

Requirements

Bachelor’s degree in a scientific discipline preferred.
Minimum 7 years’ experience in the pharmaceutical or biotech industry, with five (5) or more of those years in GCP Clinical Quality Assurance.
Proficient understanding of ICH GCP and applicable CFR regulations with a working knowledge of cGLP.
Experience providing GCP Clinical Quality Assurance guidance to Clinical teams for assigned Programs/Trials.
Experience in risk-based quality management systems and quality by design in Phase I through IV clinical trials.
Experience in conducting internal and external GCP audits (i.e., Investigational Site Audits, Process Audits, Vendor Audits, etc.), authoring audit reports, managing resulting CAPA process.
Analytical and critical thinking skills.

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCPcGLPrisk-based quality management systemsquality by designclinical quality auditaudit report authoringCAPA process managementclinical trialsregulatory compliancescientific data evaluation

Soft Skills

analytical skillscritical thinkingcommunicationcustomer interfaceteam collaborationproblem-solvingleadershiporganizational skillstimely communicationcompliance assessment