Senior Manager, GMP Vendor Quality - Remote

Overview

The Senior Manager GMP Vendor Quality at Crinetics is responsible for overseeing GMP Vendor performance and ensuring compliance with various regulations while supporting the development of therapies for endocrine diseases.

In Short

• Oversee GMP Vendor Assurance program and performance.
• Coordinate vendor audit scheduling and compliance.
• Manage contracts and consultant auditors for GMP audits.
• Support internal GMP Quality Events processes.
• Act as project manager for GMP QA initiatives.
• Write and review standard operating procedures.
• Perform vendor audits and lifecycle activities.
• Collaborate with internal and external partners.
• Ensure adherence to FDA and European regulations.
• Participate in team meetings and project discussions.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• 8 years of experience in a regulated GMP environment.
• 5 years of leadership or project management experience.
• Knowledge of FDA/EMA/ICH standards.
• Experience with Contract Management Organizations.
• Strong project management skills.
• Proficiency in MS Office and electronic QMS systems.
• GMP Lead Auditor Certification preferred.
• Experience in laboratory environments.
• Ability to travel up to 10-15% of the time.

Benefits

• Base salary range of $139,000 - $173,000.
• Discretionary annual target bonus.
• Stock options and ESPP.
• 401(k) match.
• Comprehensive health insurance plans.
• 20 days of PTO plus 10 paid holidays.
• Winter company shutdown.
• Inclusive workplace culture.
• Dog-friendly workplace.
• Equal Opportunity Employer.