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

The role has two aspects:

GCP Clinical Quality Assurance (CQA) oversight: Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, 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.

Inspection Readiness Management: Responsible for regulatory inspection readiness/preparation (sponsor and clinical investigator site) and leadership for assigned products.  Including regulatory inspection readiness/preparation risk identification, analysis, and communication.  Will possibly serve in various regulatory inspection roles and lead activities including inspection team management.

Key Responsibilities/Essential functions:

• Lead the conduct of mock regulatory inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
• Lead Cross-functional Quality Management by facilitating regulatory agency inspections and related activities (sponsor and clinical investigator site).
• 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.
• 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.

Basic Qualifications:

• Bachelor’s degree in a scientific discipline with 10+ years’ experience in the pharmaceutical or biotech industry and GCP Clinical Quality Assurance
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles.  This would include inspection risk identification, mitigation, and communication.
• Full understanding of ICH GCP and applicable CFR regulations with a working knowledge of cGLP.
• 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 (i.e., Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process.
• Ability to manage processes with continuous improvement approach.
• Analytical and critical thinking skills.
• Experience developing SOPs and Work Instructions a plus
• Experience reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs.
• Oncology and/or medical imaging clinical development experience is a plus.
• Diplomatically work and collaborate cross functionally at all levels within the organization.
• Effective communication (Oral and Written), planning, coordination, and time management skills

Oth