Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

Manager, Quality Systems- Training and Document Management

Location: Stamford, CT

Reports To:

Executive Director, Quality Assurance

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.

Loxo Oncology at Lilly is seeking a highly-motivated Manager, Quality Systems who is an excellent influencer and enjoys a fast paced, dynamic work environment. The ideal candidate has demonstrated knowledge of GXP pharmaceutical Quality Systems and possesses sound judgment, capable of obtaining tangible results in a short period of time. This individual must assist with managing Loxo Quality Systems and will work collaboratively with both internal and external colleagues to influence mindset and provide proactive compliance. 

Roles and Responsibilities of the Position*

  • Manages the Loxo training program and document management functions.
  • Must be a hands-on leader who can provide strategy for the functions as well execute processes.  Must be able to work with a sense of urgency.
  • Duties include:
    • Processing SOPs through document lifecycle (e.g. SOP creation, QC review, circulate for review, approval, periodic review, etc.).
    • Reviewing of SOPs for compliance with GxPs and regulatory requirements.
    • Driving the Loxo training program which includes assisting in curricula development through approval and managing employee training files.
    • Assigning training and ensuring training is up to date.
    • Collaborates with internal Loxo departments and with Loxo’s parent company to identify training needs.
    • Collaborates with IT and QA Program Manager to problem solve system related issues.
  • Additional responsibilities may include supporting inspection readiness, metrics reporting for Quality system elements, etc.
  • Works with internal departments to ensure continuous improvement of processes / procedures and quality of work product.

Required Qualifications and Background

  • Bachelor's Degree is required in science, health or related field 5-7+ years’ experience in the Biotech/Pharmaceutical industry (21 CFR 210 and 211).
  • Working knowledge of IT Quality System solutions and associated compliance requirements, which includes but is not limited to; system implementation, execution and change management (Veeva systems a plus).
  • Strong working knowledge of global regulations and guidelines for early phase pharmaceutical development (e.g. FDA/EU and ICH).
  • Broad and direct experience supporting regulatory authority inspections.
  • Flexible in the face of shifting needs and/or priorities.
  • Able to interface well with all levels of personnel, including peers and other department heads such as: IT, Clinical Operations, Data Management, CMC, Clinical Science, Regulatory, Biostatistics, Drug Safety, Translational Research, Supply Chain and Project / Program Management.
  • Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
  • Excellent communications skills, both written and verbal.
  • Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
  • Strategic thinker, open-minded and flexible to adopting new ideas.
  • Motivated, committed and self-managed.
  • Willingness to work in a dynamic and changing corporate environment.
  • Requires a flexible work schedule to accommodate program priorities and international activities as needed.
  • Exceptional attention to detail.

Physical Demands / Travel

There are no physical demands for this position. 

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

Ability to travel 15%. No specific work demands.

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.