Associate Director, GCP Clinical Quality Assurance

Associate Director, GCP Clinical Quality Assurance

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

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.

Line management of junior staff is possible and would include but not be limited to : regular 1 : 1s, mentoring conversations, and providing GCP counsel on escalated topics.

Key Responsibilities / Essential Functions

• 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.
• Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical / clinical development programs, vendors, and cross-functional groups.
• Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and / or inspections and perform effectiveness checks.
• Author audit reports and coordinate supporting documentation; manage same in QMS.
• Peer review reports authored by colleagues.
• Identify non-compliance trends and systematic risks for assigned areas of responsibility
• Contribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-Systems
• Support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
• Support Quality Management by facilitating regulatory agency inspections and related activities.
• Other duties as assigned

Basic Qualifications

Other Requirements

Core Values

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.