Senior Manager, Quality Control - Remote

Overview

The Senior Manager, Quality Control will lead the Quality Control activities for a late-stage small molecule oncology program, ensuring compliance with GMP and GDP standards.

In Short

• Lead Quality Control activities for oncology programs.
• Work with CROs/CMOs for testing and documentation.
• Ensure compliance with GMP and GDP standards.
• Review analytical release and stability data.
• Investigate and resolve analytical test failures.
• Collaborate with cross-functional teams.
• Author and review regulatory submission documents.
• Participate in vendor and internal audits.
• Drive and deliver multiple projects within timelines.
• Adapt to changes in job demands and organizational structure.

Requirements

• BS in chemistry or related discipline with 8+ years of experience.
• Strong understanding of cGMP/ICH regulations.
• Knowledge of analytical testing concepts.
• Ability to author and review documentation.
• Experience with compliance in drug development.
• Proven track record in solving analytical challenges.
• Proficiency with JMP and statistical analysis preferred.

Benefits

• Equal employment opportunities.
• Supportive work environment.
• Opportunities for professional growth.