What are the responsibilities and job description for the Associate Manager/Manager - QA Audits position at Loxo@Lilly?
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.
Loxo@Lilly is seeking a highly motivated QA Associate Audit Manager who is an excellent influencer and enjoys a fast paced, dynamic work environment. The ideal candidate has demonstrated strong knowledge in GXPs for small and large molecule pharmaceuticals in both clinical trials and product manufacturing. The candidate will be responsible for working the third party risk management team as well as managing assigned audits (scheduling, conducting, following up and closing).
**Roles and Responsibilities of the Position:**
Conducts audits for which Loxo@Lilly is responsible.
Key activities include, but are not limited to:
o Plan, execute, and monitor Loxo@Lilly qualification audits
o Plan and execute internal audits
o Support development of an audit schedule
o Support audits conducted of Loxo@Lilly by outside auditors
o Partner with Loxo@Lilly functional areas to support Health Authority audits
o Partner with Loxo@Lilly Third Party Risk Management Team to determine required audits
o Partner with parent company to support strategic auditing initiatives
Provide input in Quality Management review, which includes metric generation and data analysis.
Drive the inspection readiness program for clinical programs.
Support process improvement projects.
Perform other duties as assigned.
**Required Qualifications and Preferred Background:**
Bachelor's Degree is required in science, health or related field 5-7 years experience in the Biotech/Pharmaceutical industry
Working knowledge of Microsoft 365 suite, Veeva, etc.
Comprehensive working knowledge of GCPs, GCLPs, CAP and CLIA requirements.
Strong working knowledge of global regulations and guidelines (e.g., FDA/EU and ICH) for early phase pharmaceutical development in both clinical trials execution and drug substance/drug product manufacturing (small and large molecule).
Ability to adapt quickly to shifting needs and/or priorities.
Strong Project Management skills in order to manage projects at various stages and effectively multi-task.
Able to interface well with all levels of personnel.
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.
**Additional Locations for this Role:**
Louisville, CO
South San Francisco, CA
Stamford, CT
_Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Manager level position could range from between $78,000 to $114,498 and $103,200 to $151,423 for the Manager position, and will depend in part, on the successful candidate's 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 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:**
No physical demands.
_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 to travel 50%
No specific work demands.
_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 address blocked ] - Click here to apply to Associate Manager/Manager - QA Audits _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._
Loxo@Lilly is seeking a highly motivated QA Associate Audit Manager who is an excellent influencer and enjoys a fast paced, dynamic work environment. The ideal candidate has demonstrated strong knowledge in GXPs for small and large molecule pharmaceuticals in both clinical trials and product manufacturing. The candidate will be responsible for working the third party risk management team as well as managing assigned audits (scheduling, conducting, following up and closing).
**Roles and Responsibilities of the Position:**
Conducts audits for which Loxo@Lilly is responsible.
Key activities include, but are not limited to:
o Plan, execute, and monitor Loxo@Lilly qualification audits
o Plan and execute internal audits
o Support development of an audit schedule
o Support audits conducted of Loxo@Lilly by outside auditors
o Partner with Loxo@Lilly functional areas to support Health Authority audits
o Partner with Loxo@Lilly Third Party Risk Management Team to determine required audits
o Partner with parent company to support strategic auditing initiatives
Provide input in Quality Management review, which includes metric generation and data analysis.
Drive the inspection readiness program for clinical programs.
Support process improvement projects.
Perform other duties as assigned.
**Required Qualifications and Preferred Background:**
Bachelor's Degree is required in science, health or related field 5-7 years experience in the Biotech/Pharmaceutical industry
Working knowledge of Microsoft 365 suite, Veeva, etc.
Comprehensive working knowledge of GCPs, GCLPs, CAP and CLIA requirements.
Strong working knowledge of global regulations and guidelines (e.g., FDA/EU and ICH) for early phase pharmaceutical development in both clinical trials execution and drug substance/drug product manufacturing (small and large molecule).
Ability to adapt quickly to shifting needs and/or priorities.
Strong Project Management skills in order to manage projects at various stages and effectively multi-task.
Able to interface well with all levels of personnel.
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.
**Additional Locations for this Role:**
Louisville, CO
South San Francisco, CA
Stamford, CT
_Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Manager level position could range from between $78,000 to $114,498 and $103,200 to $151,423 for the Manager position, and will depend in part, on the successful candidate's 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 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:**
No physical demands.
_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 to travel 50%
No specific work demands.
_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 address blocked ] - Click here to apply to Associate Manager/Manager - QA Audits _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._
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Salary : $78,000 - $114,498
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