Manager, Quality Assurance, GCP (Multiple Locations)

Loxo Oncology at 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 Oncology at 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 Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.The Manager, Quality Assurance is responsible for all aspects of Quality Assurance and GCP compliance. The Manager Quality Assurance will establish and execute quality plans, policies and quality system elements related to GCP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, CAPAs, and work closely with the Clinical Operations team. The Manager, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GCP international regulatory environment and provide GCP guidance in Quality related areas.Role and Responsibilities of the Position:* Liaise across departments to proactively identify opportunities to streamline and strengthen GCP process* Serves as GCP SME in writing and revising SOPs.* Reviews and approves Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System* Represents GCP expertise and acts as the QA point person on cross-functional clinical study teams* Keeps current with global health authority laws and regulations 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.)* Liaises audit requirements between clinical study teams and auditing group and follows up on audits with the auditee* Utilizes the Loxo Quality Systems to manage Quality system elements* Drives inspection readiness activities for project teams.* Supports external Health Authority inspectionsRequired Qualifications and Background* Bachelor’s degree with 5- 7 years’ experience working in either a clinical compliance or clinical Quality group* Must be a hands on Leader who can provide guidance and execute daily tasks* Demonstrated Quality Management System experience (GCP specific QMS experience preferred)* Demonstrated Issue Management and CAPA experience in a clinical environment.* Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.* Self-motivated with the ability to work effectively in a dynamic environment* Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization* Good problem solving, written and verbal communication skill* Ability to effectively manage multiple priorities with a sense of urgency* Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations* Attention to detail and accuracy of work.* Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator* Strong communication skills both written and oral* Works with a sense of urgency and has the ability to multi-task and shift priorities rapidly to meet tight deadlines.* Professional demeanor and appearance and an excellent written and verbal communicator.* Detail oriented and well organized* Good and thoughtful listener* Critical thinker and solution oriented* Enthusiastic, self-motivated and a self-starterAvailable Locations for this role* Stamford, CT* South San Francisco, CA* US Based-Remote* 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.