Loxo@Lilly Senior Associate Manager/Manager, IT Quality Assurance in Augusta, Maine
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
The Senior Associate Manager/Manager, IT Quality Assurance (QA) will partner with IT and business leaders to support GxP IT system activities. This includes but is not limited to providing QA guidance on current regulatory and industry expectations, reviewing and approving documentation associated with GxP IT system implementation and/or modifications.
Roles and Responsibilities of the Position
Design and execute validation documentation and deliverables that include, but are not limited to validation protocols, test scripts, trace matrices, validation reports, etc.
Conduct periodic reviews for computerized systems.
Assist with IT system classification for GxP systems.
Support business partners with Business Continuity Plans
Support the review of data integrity and regulatory assessments to ensure compliance with applicable regulatory requirements, internal and external standards (e.g. Part 11, GAMP, etc.).
Perform the review and approval of IT system related change controls to ensure completeness and compliance with internal and external requirements.
In addition to change controls, provide guidance on all IT related Quality system elements such deviations, CAPAs and SOPs.
Author and review policies, standard operating procedures and work instructions related to IT activities and QA roles and responsibilities.
Perform the review and approval of IT system SDLC documentation that includes, but is not limited to validation plans, reports, deviations, trace matrices, and executed UAT documentation.
Work cross functionally with business areas to support IT system implementation and upgrades.
Required Qualifications and Preferred Background
BA/BS in science or engineering or relevant field is required
A minimum of 5-7 years of experience working in the Biotech or Pharmaceutical regulated industry in IT QA
Current on regulatory and industry requirements and expectations (e.g. data integrity, GAMP, etc).
Experience in executing, reviewing and approving Quality system elements (e.g. deviations, change controls, CAPAs, etc.)
Self-starter and ability to make decisions with minimal oversight.
Strong attention to detail and accuracy of work.
Ability to multitask and work in a fast-paced environment to meet tight deadlines.
Strong problem-solving skills and ability to lead process improvements.
Strong leadership skills and the ability to lead cross functional meetings.
Strong Quality and business knowledge to determine when to escalate issues when necessary.
Ability to work in a matrixed environment.
Demonstrated ability to work well with other accomplished professionals at all levels of the organization.
Strong internal and external collaborator.
Strong communication skills both written and oral.
Proficient in Microsoft Office suite and applications.
Ideal candidate will also have:
Veeva Vault experience strongly preferred (QualityDocs, QMS, eTMF, RIM)
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Associate Manager level position could range from between $89,750 to $131, 672 and at the Manager level 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 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.
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 the employee’s home 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@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.
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 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.