Senior Specialist, Quality Management Systems

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

As a Sr. Specialist of Quality Systems, you will be the architect and guardian of the frameworks that ensure our life-saving products meet the highest safety and efficacy standards. You won’t just be "checking boxes"; you’ll be streamlining the very processes—from CAPAs to Change Controls—that allow innovation to move at the speed of science.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Directly support the Associate Director, Quality Systems with management of Quality System procedures and computer systems (eg, Veeva QualityDocs, LMS, QMS, and other modules).
• Interact and present to various internal and external audiences: may present to internal/external project team.
• Train and educate employees on the use of Veeva Vault and the Crinetics QMS processes and may provide training to internal interdisciplinary teams.
• Manage and oversee day-to-day QMS using the electronic Quality Management System while leading continuous improvement efforts of those systems and processes.
• Report quality metrics and key performance indicators to monitor the QMS performance.
• Ensure compliant use of QMS electronic system in collaboration with GxP Quality Leads.
• Stay up to date with industry trends and best practices related to Veeva Vault and QMS.
• Maintain up-to-date knowledge of the GxP quality landscape, and monitor periodic updates to regulations, and guidelines. Proactively implement necessary updates to QMS.
• Recommend changes to GXP policies and establish procedures / work instructions that affect Quality Assurance.
• Support inspection-readiness activities and regulatory inspections.
• Foster a Quality culture that values innovation, continuous improvement, and personal accountability
• Execute other duties and project, as assigned by the Associate Director, Quality Systems.

Education and Experience:

Required:

• Bachelor’s degree or Master’s degree with a minimum of 3-5 years of relevant Quality Assurance GxP experience in a biotech/pharmaceutical setting, or Doctorate degree with 2-4 years of relevant experience.
• Experience working with internal partners in various regulated disciplines (GMP, GCP, GLP, GVP).
• Experience with the use, change control, and testing of Veeva QMS.
• Working knowledge and understanding of US and international GMP regulations and guidance documents. Additional understanding of GCP, GLP, and pharmacovigilance regulations is a plus.
• Understanding and experience with computer system validation, change control and 21 CFR Part 11, Annex 11, and GAMP 5.
• Ability to handle multiple projects simultaneously and prioritize tasks in a dynamic environment.
• Ability to travel domestically and internationally as required.
• Ability to remain objective/autonomous in overseeing the Quality Program, while at the same time taking ownership and proactively working with functional departments to achieve the desired quality objectives.
• Demonstrated project management skills with ability to manage multiple projects and execute in adherence to timelines.
• Demonstrates analytical and problem-solving abilities to resolve complex issues that involve numerous components
• Sound collaboration, interpersonal, verbal, and written communication skills.
• Sound presentation skills to both internal and external audiences.
• Able to work on issues where analysis of situations or data requires conceptional thinking and knowledge.
• Has knowledge and experience using a risk-based approach.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work