Loxo@Lilly Associate Director, GMP Auditor 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.
Loxo@Lilly is seeking a highly motivated QA Audit Professional 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 manage the GxP audit program for third party qualifications as well as the internal audit program. The candidate will execute GxP audits as well as collaborate both internally and externally to oversee the planning and execution of all audits.
Roles and Responsibilities of the Position:
Conducts Audits for which L@L is responsible
Key activities include, but are not limited to:
o Plan, execute, and monitor L@L qualification audits
o Plan and execute internal audits
o Support development of an audit schedule
o Support audits conducted of L@L by outside auditors
o Partner with L@L functional areas to support Health Authority audits
o Partner with L@L 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.
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 8+ years experience in the Biotech/Pharmaceutical industry
Working knowledge of Microsoft 365 suite, Veeva, etc.
Comprehensive working knowledge of global GMPs 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.
Loxo@Lilly currently anticipates that the base salary for the Associate Director level position could range from between $109,500 to $160,600 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.
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.
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@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.