Senior Specialist, Quality Management Systems

Crinetics Pharmaceuticals • San Diego, CA

1d

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Additional understanding of GCP, GLP, and pharmacovigilance regulations is a plus.

Responsibilities

• 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.

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level