Associate Director - Clinical Operations Quality Assurance

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com.

Job Overview:

The Associate Director, Clinical Operations Quality Assurance is an integral role within the global Avid Quality Assurance (QA) function, ensuring the GCP Quality Management System (QMS) is well-defined, effectively executed, and aligned with quality risk management principals to minimize regulatory risk. This role leads GCP QA activities and establishes functional QA procedures for sponsor oversight of internal operations and contracted clinical investigations.

In collaboration with Avid Clinical Operations and Imaging Operations, the Associate Director of Clinical Operations QA ensures that clinical sites, imaging centers, investigators, and other contracted third parties are qualified and maintained according to risk-based industry standards and study documentation. 

This position supports cross-functional teamwork and provides QA support to Clinical Operations, Imaging Operations, Medical, Statistics, and Avid QA team members. This role works with Global Medical Quality Organization to establish and maintain Avid’s practices with corporate standards, collaboration with Lilly team members, and monitors regulatory intelligence for evolving guidelines.

Responsibilities:

• Lead and manage the GCP external audit program by:

  • 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 making decisions that relate to patient safety and efficacy data, product quality, including perceived quality related issues and deviation/CAPA management

• Evaluate the quality systems, operational controls, adequacy of facilities, and qualifications/training of personnel of potential third-party organizations against proposed services within the parameters set by the contract/agreement and study protocols

• Align and implement global Quality Management System (QMS) standards, ensuring low compliance risk through internal audits and periodic self-assessments based on risk and sponsor responsibilities

• Determine and lead efforts to continually educate applicable Avid personnel on GCP inspection trends

• Identify, assess, and lead, as appropriate, GCP QMS continuous improvement efforts in corroboration with QA and/or cross functional team members o remain current to regulatory and corporate standard expectations

• Ensure there are adequate procedures, tracking, and reporting systems in alignment with industry standards and corporate policies for work responsibilities and GCP document management, performance management, change control, deviations/investigations, complaint management, computer systems, data integrity, risk analysis and management, corrective and preventative actions, training, audit and inspection management, regulatory intelligence management

• Collaborate with team members to ensure adequate visibility of performance and risks. Escalate performance to management, as required.

• Lead, support Avid Quality Assurance efforts in GCP investigations and critical events. Escalate specified events, significant GCP quality related issues to appropriate levels of quality management in a timely manner

• Review clinical study protocols to ensure compliance to industry standards and clinical imaging data for accuracy and compliance to study protocol documents in support of regulatory inspections

• Lead GCP Inspection Readiness and support GCP Regulatory Inspections and/or Reviews

• Lead, plan, develop presentation materials for periodic management review of key p