Manager, GLP and Biomarker Quality

Employment Type

: Full-Time

Industry

: Miscellaneous



Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, GLP and Biomarker Quality is responsible for all aspects of Quality Assurance supporting GLP and Biomarker Operations. The Manager Quality Assurance will establish and execute quality plans, policies and quality system elements related to GLP activities. This position will support GLP operations and the vendor management program for biomarker operations. The Manager, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance with CAP/CLIA, GLPs, GCPs, and international requirements.

Roles and Responsibilities of the Position*

  • Act as liaison across departments to proactively identify opportunities to streamline and strengthen the vendor qualification process.
  • Facilitate the qualification process for biomarker, diagnostic, and clinical laboratory vendors and represent QA at the qualification forums.
  • Maintain detailed list of GLP/clinical laboratory/biomarker/diagnostic vendors and their current status.
  • Develop SOPs that support the QA role in GLP operations.
  • Serve as QA SME when SOPs are written or revised in this area, as well as general GxP SOPs.
  • Perform a QA review of GLP toxicology reports.
  • Perform QA review of technical and regulatory documents that support clinical trials.
  • Represent QA on cross-functional clinical study teams.
  • Keeps current with global health authority laws and regulations and implements process improvements resulting from new/revised regulations or guidance.
  • Utilizes the Loxo Quality Systems to manage Quality system elements.
  • Supports external Health Authority inspections, as needed.
  • Required Qualifications and Background

  • Bachelor’s degree with 10 or more years of experience working in either early phase clinical compliance or clinical quality group.
  • Demonstrated knowledge in CAP/CLIA certifications and working knowledge of GLPs and GCPs.
  • Experience working with third parties, auditing, and vendor qualification.
  • Demonstrated Quality Management System experience (SOPs, training, document control, auditing, etc.).
  • Experience working in a regulated environment (e.g. FDA, EMA, etc.).
  • Self-motivated with the ability to work effectively in a dynamic environment.
  • Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization.
  • Good problem solving, written and verbal communication skill.
  • Ability to effectively manage multiple priorities with a sense of urgency.
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
  • Attention to detail and accuracy of work.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Physical Demands / Travel

    The physical demands of this job are consistent with light office duties.

    The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Work Environment

    This position’s work environment is in an office environment.

    The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

    *To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Loxo Oncology, Inc. 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.


    Launch your career - Create your profile now!

    Create your Profile

    Loading some great jobs for you...