Senior Manager, Quality Compliance

Role Overview

We are seeking an experienced Senior Manager, Quality Compliance to join our growing global organization. This role will lead and coordinate Quality Compliance activities across functional areas, ensuring alignment with global regulatory requirements and internal standards.

What You Will Do

The successful candidate will act as a key point of contact between Cytokinetics and its contract service providers, managing the Product Quality Complaint program, as well as supporting regulatory intelligence, inspection readiness, and internal/external audits.

Why It Might Be a Fit

The role requires a strong working knowledge of global GMP/GDP regulations and emerging regulatory trends, experience with Product Quality Complaint handling, and the ability to influence and collaborate effectively across all organizational levels.

Requirements

• Bachelor’s degree (BSc) or higher in a relevant scientific discipline
• Minimum of 8+ years’ experience in pharmaceutical or biopharmaceutical manufacturing and quality
• Direct experience with Product Quality Complaint handling within the US and EU is required. Experience in other territories is preferred.
• Strong working knowledge/interpretation of global GMP/GDP regulations and emerging regulatory trends
• Experience working with external partners or contract organizations, including Quality oversight
• Experience dealing with regulatory authority inspections is preferred
• Strong investigation handling, communication (written/verbal), problem-solving skills
• Ability to influence and collaborate effectively across all organizational levels
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Strong ability to work independently, demonstrating initiative and sound judgment
• Ability to navigate through ambiguity and identify appropriate solutions in order to progress activities
• Excellent organizational skills with the ability to manage multiple priorities effectively
• Proficiency in Microsoft Office applications
• Ability to travel up to 10% annually

Benefits

• Dental insurance
• Vision insurance
• Salary range €102,800-€128,500 gross annually
• Annual Gender Equality Index
• Fair and transparent pay practices
• Equal pay for work of equal value