Eli Lilly and Company

Associate Director, Clinical Operations Quality Assurance

Eli Lilly and Company

full-time

Posted on:

Origin:  • 🇺🇸 United States • Pennsylvania

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Salary

💰 $111,000 - $162,800 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead GCP QA activities and establish functional QA procedures for sponsor oversight of internal operations and contracted clinical investigations
  • Ensure clinical sites, imaging centers, investigators, and other contracted third parties are qualified and maintained according to risk-based industry standards and study documentation
  • Support cross-functional teamwork and provide QA support to Clinical Operations, Imaging Operations, Medical, Statistics, and Avid QA team members
  • Work with Global Medical Quality Organization to establish and maintain Avid’s practices with corporate standards and monitor regulatory intelligence for evolving guidelines
  • Lead and manage the GCP external audit program including designing procedures for sponsor QA responsibilities and site quality audits
  • Oversight and monitoring of investigational sites and third-party organizations
  • Establish and provide risk-based quality oversight of GCP external organizations
  • Support GCP operations in decisions related to patient safety, efficacy data, product quality, deviation/CAPA management
  • Evaluate quality systems, operational controls, facilities, and qualifications/training of personnel of third-party organizations
  • Align and implement global QMS standards through internal audits and periodic self-assessments
  • Educate Avid personnel on GCP inspection trends and lead continuous improvement efforts
  • Ensure adequate procedures, tracking, and reporting systems in alignment with industry standards and corporate policies for GCP document management, change control, deviations/investigations, complaint management, computer systems, data integrity, risk analysis, CAPA, training, audit management, regulatory intelligence
  • Lead/support Avid QA efforts in GCP investigations and critical events and escalate significant issues
  • Review clinical study protocols for compliance and clinical imaging data accuracy
  • Lead GCP Inspection Readiness and support regulatory inspections and/or reviews
  • Develop presentation materials for management review of KPIs, regulations, inspection themes, and inspection readiness
  • Provide/support GCP QA expertise toward computer systems qualification and validation and ensure contracted third party systems meet regulatory standards
  • Coordinate and verify GCP QMS is established and effective from protocol inception through Clinical Study Report completion

Requirements

  • Bachelor's Degree in Science, Technology, Engineering, or Math
  • Minimum 5 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical research space
  • Experience in managerial or leadership roles (preferred)
  • Experience in QA Audits of Clinical sites and Third party organizations (preferred)
  • Solid understanding of applicable GCP regulations, quality risk management, and interpret and apply them for Quality Assurance responsibilities
  • Experienced and able to demonstrate the ability to audit GCP processes, operations, and Quality Management Systems
  • Strongly experienced with QA review of Clinical Protocols, CAPA reports, SOPs, change control processes, deviation/investigation reports, computer systems validation, QA agreements, audit reports
  • Ability to write and provide technical review of root cause investigations
  • Experienced in leading the preparation, hosting and follow-up activities associated with regulatory inspections and audits
  • Strong verbal and written communication skills
  • Experience working within document management and tracking systems such as Veeva (preferred)
  • Proficient in MS Office
  • Ability to work independently and bring up issues
  • Meeting facilitation and ability to lead projects
  • Ability to identify and handle risks to project timelines
  • Ability to simplify complex processes/problems and propose alternate solutions
  • Ability to assess Quality System related procedures for their efficiency and make improvements
  • Multi-lingual a plus