Associate Director, GCP Clinical Quality Assurance

Role Summary

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.

Responsibilities

• 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

Qualifications

• Bachelor‚Äôs degree in a scientific discipline and 7+ years‚Äô 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 appliable 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 thru IV clinical trials.
• Experience in conducting internal and external GCP audits (Ie. 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.
• Excellent communication (Oral and Written), planning, coordination, and time management skills
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus.

Other Requirements

• Up to 20% travel primarily in North America and Canada as required
• Hybrid position (3 days onsite in Bedford office)

Education

Skills

• GCP Compliance
• Quality Assurance
• Audit Planning and Execution
• CAPA Management
• Regulatory Inspection Readiness
• Quality Management Systems