Executive Director, Clinical Quality Assurance
Posted on: January 24, 2023
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 Executive Director, Clinical Quality Assurance is
responsible for end-to-end Clinical Quality Assurance. The
Executive Director, Clinical Quality Assurance will be responsible
for the oversight and execution of third-party qualifications,
inspection readiness program, quality plans, policies and quality
system elements related to clinical quality activities in support
of clinical programs. The Executive Director, Clinical Quality
Assurance will establish, maintain, and ensure effectiveness of
quality programs and documentation to assure compliance in a
international regulatory environment and provide guidance in
clinical Quality related areas.Roles and Responsibilities:
- Responsible for leading the clinical Quality team which
includes third party and internal auditing and day to day clinical
study team support.
- Liaise across Loxo@Lilly departments and with Lilly colleagues
to proactively identify opportunities to streamline and strengthen
clinical Quality process.
- Reviews and approves internal and external audit reports,
Quality Events and associated Corrective and Preventative Actions
within a regulated Quality Management System.
- Represents Clinical Quality expertise across the Loxo @Lilly
development organization in GCLP and GCP.
- 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.).
- Leads external Health Authority inspections and internal
- Provides guidance in global regulatory reporting requirements
(e.g. serious breach, etc).
- Establishes a global inspection readiness program.Required
Qualifications and Preferred Background:
- Bachelors degree with 15 or more years experience working in
clinical development, preferably in either a clinical compliance or
clinical Quality Assurance.
- Must be strategic as well as a hands-on leader who can see the
big picture while providing guidance to execute daily tasks
- Must have experience in managing a team of QA
- Demonstrated Quality Management System experience appropriate
for the clinical development.
- Demonstrated understanding in third party/internal Quality
audits, Issue Management and CAPA in a clinical environment.
- Experience leading FDA or other Health Authority
- Strong knowledge of global clinical trial regulations (e.g.
ICH, FDA, etc) and guidelines, particularly in GCLP, CAP, CLIA and
- Proficient in risk management principles
- Self-motivated with the ability to work effectively in a
- Strong leadership with demonstrated ability to interface with
senior leaders and different levels of the organization to provide
solutions to complex situations.
- Excellent critical thinking and problem-solving skills and
- Ability to effectively manage multiple priorities with a sense
- Strong track record of project management, stakeholder
management, collaboration skills and negotiation of complex
- Attention to detail and accuracy of work.
- Demonstrated ability to work well with other accomplished
professionals within and across functions/teams.
- Strong communication skills both written and oral.Loxo
Oncology, Inc. (Loxo) currently anticipates that the base salary
for the Executive Director level position could range from between
$144,000 to $232,100 and will depend, in part, on the successful
candidates qualifications for the role, including education and
experience. This position will also 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.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 positions work environment is in an office setting
with up to 25% travel required.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@Lilly (Eli Lilly and Company) 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@Lilly (Eli Lilly and
Company) 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
firstname.lastname@example.org 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.
Keywords: Loxo@Lilly, Charleston , Executive Director, Clinical Quality Assurance, Executive , Charleston, West Virginia
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