Indianapolis, Indiana

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 35,000 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 .

Responsibilities:

The Manager, Clinical Operations Quality Assurance is an integral role within the global Avid Quality Assurance (QA) function that ensures the GCP Quality Management System (QMS) is defined, executed, remains effective, and operates using quality risk management principals to drive a low risk to regulatory compliance. This role is responsible for leading GCP QA responsibilities and establishing functional QA procedures for study sponsor quality oversight of internal operations and contracted clinical investigations. In collaboration with Avid Clinical Operations and Imaging Operations, the Manager of Clinical Operations QA ensures clinical sites, investigators, and other associated contracted third parties are qualified and maintained to according to risk-based industry standards and study related documents.

This position participates in and/or establishes mechanisms to collaborate and provide QA support to Clinical Operations, Imaging Operations, Medical, Statistics, and Avid Quality Assurance team members, for its success. This individual also works with Lilly Medical Quality to establish and maintain Avid's alignment to corporate standards, best practices, collaboration with Lilly team members, and monitors regulatory intelligence for evolving guidelines.

  • Establish, implement, manage the annual plan, and execute the GCP external audit program by:
    • Designing procedures for sponsor QA responsibilities and site quality audits
    • Verifying there is adequate 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
  • Assure a low risk to compliance, product quality and patient safety by establishing and overseeing an internal audit/self-assessment program and ensure assessments are performed at periodic intervals 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
  • Oversees 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
  • Other duties as assigned


Basic Qualifications:

  • (4) year degree such as BSc, or MS in Pharmacy, or discipline relevant to Clinical Trials
  • At least 5 years of Quality Assurance experience in pharmaceutical GCP operations or related quality technical role in the medical space


Additional Skills/Preferences:

  • Demonstrated ability to supervise staff
  • Strong experience in QA Audits of Clinical sites and Third party organizations is preferred
  • Working knowledge of applicable GCP regulations, quality risk management, and the ability to 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 and TrackWise preferred
  • Proficient in MS Office
  • Ability to work independently and escalate issues, when necessary
  • Meeting facilitation and ability to lead projects
  • Ability to identify and manage risks to project timelines
  • Ability to simplify complex processes/problems and propose alternate solutions
  • Ability to assess Quality System related procedures for their effectiveness and make improvements, as necessary
  • Multi-lingual a plus


Additional Information:

  • Ability to travel in US and international up to 20-30%, as required


Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-34360.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Indianapolis, Indiana

Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
Our mission 
We make medicines that help people live longer, healthier, more active lives.
Our values
Integrity, excellence, respect for people
Our vision 
We will make a significant contribution to humanity by improving global health in the 21st century.

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