Clinical Quality Assurance Manager

3 weeks ago


Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time
Job Summary

Lantheus Medical Imaging Inc is seeking a highly skilled Clinical Quality Assurance Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the execution and performance of our quality system elements, including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents.

Key Responsibilities:

  • Develop and execute 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.
  • 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.

Requirements:

  • Bachelor's degree in a scientific discipline and 3 to 7 years' experience in the pharmaceutical or biotech industry with 2 to 5 years in Clinical Quality Assurance.
  • 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.

Additional Requirements:

  • Up to 20% travel primarily in North America and Canada.
  • This position is site-based and requires a presence on-site in Bedford, MA three days per week.

Lantheus Medical Imaging Inc is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees and applicants.



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