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.

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 performance indicators emerging or changing regulations, regulatory inspection themes, and inspection readiness in alignment or in spirit of Lilly corporate standards and applicable regulatory expectations

Provide/support GCP QA subject matter expertise toward computer systems qualification and validation or ensures computer systems employed by contracted third parties meet regulatory data integrity, computer system qualification, and electronic records and signatures standards

Coordinates and verifies the GCP Quality Management System (QMS) is established and effective for all components of GCP operations from protocol inception through Clinical Study Report completion and that for Investigational Product used in Avid/Lilly-sponsored trials

Basic Qualifications:

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

Additional Skills/Preferences:

Experience in managerial or leadership roles.

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 preferred

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

Additional Information:

Ability to travel in US and international up to 20-30%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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