Manager, Quality Assurance - GCP
Quality Assurance /
Loxo@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@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 Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Manager, Quality Assurance is responsible for all aspects of Quality Assurance and GCP compliance. The Manager, Quality Assurance will establish and execute quality plans, policies and quality system elements related to GCP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, CAPAs, and work closely with the Clinical Operations team. The Manager, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GCP international regulatory environment and provide GCP guidance in Quality related areas.
Roles and Responsibilities of the Position:
- Liaise across departments to proactively identify opportunities to streamline and strengthen GCP processes
- Serves as GCP SME in writing and revising SOPs
- Reviews and approves Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System
- Represents GCP expertise and acts as the QA point person on cross-functional clinical study teams
- Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance
- Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.)
- Liaises audit requirements between clinical study teams and auditing group and follows up on audits with the auditee
- Utilizes the Loxo Quality Systems to manage Quality system elements
- Drives inspection readiness activities for project teams
- Supports external Health Authority inspections
Required Qualifications and Preferred Background:
- Bachelor’s degree with 5- 7 years’ experience working in either a clinical compliance or clinical quality group
- Must be a hands-on leader who can provide guidance and execute daily tasks
- Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
- Demonstrated Issue Management and CAPA experience in a clinical environment
- Strong knowledge of global clinical trial regulations and guidelines
- Proficient in risk management principles
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
- Self-motivated with the ability to work effectively in a dynamic environment with initiative and great organization skills
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
- Ability to deal with ambiguity, creative and pragmatic approach to problem solving
- Ability to be adaptable and 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.
- Excellent interpersonal and communication skills (both written and oral)
- Works with a sense of urgency and has the ability to multi-task and shift priorities rapidly to meet tight deadlines
- Professional demeanor and appearance and a team player
- Detail oriented with analytical and problem-solving skills and well organized
- Good and thoughtful listener
- Critical thinker and solution oriented
- Enthusiastic, self-motivated and self-starter
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
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.
This position’s work environment is in an office.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities 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.
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).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email email@example.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.