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Loxo@Lilly Director, GMP Quality Assurance (Multiple Locations) in Helena, Montana

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 Director, GMP Quality Assurance is responsible for all aspects of Quality Assurance and GMP compliance. The Director, GMP Quality Assurance will establish and execute quality plans, policies and quality system elements related to GMP activities. This position will support the design, implementation and maintenance of QA and compliance programs and act as the Quality representative on CMC project teams. The Director, GMP Quality Assurance will maintain GMP quality programs and documentation to assure compliance in a GMP international regulatory environment and provide GMP guidance in Quality related areas. This position will report to the Vice President, Quality Assurance.

Roles and Responsibilities of the Position:

  • Lead GMP QA Team and point person for GMP QA

  • Responsible for oversight of release and disposition of drug substance and drug product for clinical use

  • Negotiate Quality Agreements

  • Support new business ventures from a GMP QA perspective

  • Responsible for process improvement projects in GMP QA

  • Support transition of products between Loxo and Lilly organizations

  • Liaise with QPs for Batch release activities

  • Interact and develop relationships with contract manufacturing organizations, internal Loxo departments, and Lilly Quality departments

  • Oversight of review and approval of product specifications, product labeling, master batch records, deviations and CAPAs, etc.

  • Update Quality SOPs in support of Loxo GMP Quality

  • Ensure compliance with corporate policies and procedures as well as health authority laws and regulations

  • Support regulatory inspections of Sponsor and contract organizations

  • Provide reviews of regulatory dossiers (IND, IMPD, NDA)

  • Mentor junior Quality team members and act as a back up to the Vice President

Required Qualifications and Preferred Background:

  • Minimum BS, master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field

  • 10+ years current work experience in pharmaceutical industry Quality Assurance required

  • Knowledge of CMC and analytical laboratories in small molecules and Biologics

  • Experience in working in all phases of drug development (Phase 1 through commercial)

  • Working knowledge of ex-US batch release requirements (i.e., Qualified Person requirements)

  • Solid and demonstrable knowledge of international GMP regulations and guidelines, and industry practices

  • Expert knowledge in Quality systems

  • Experience supporting regulatory inspections

  • Strong organization and time management skills

  • Attention to detail with an ability to perform critical review of various types of documents

  • Outstanding written and verbal skills

  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.

  • Strong written and oral communication skills

  • Ability to multi-task and shift priorities rapidly to meet tight deadlines

  • Detail oriented and well organized

  • Good and thoughtful listener

  • Critical thinker and solution oriented

  • Enthusiastic, self-motivated, self-starter, and keen to improve processes and overcome inefficiencies

  • Proficient in Microsoft Office suite and applications

Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position level could range from between $135,300 to $198,500 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 above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Available locations for this role:

  • Stamford, CT

  • South San Francisco, CA

  • Louisville, CO

  • Indianapolis, IN

Physical Demands/ Travel:

The physical demands of this job are consistent with light office duties .

• Ability to travel to vendor sites (up to 10%).

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 position’s work environment is in an office setting with up to 10% 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 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 loxoaccommodation@loxooncology.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.

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