Senior Manager, Quality EU or US (remote, full time)

Job purpose

The Senior Manager, Quality is responsible for leading the operational excellence and oversight of core Quality Management System (QMS) processes, including deviations, corrective and preventive actions (CAPA), risk management, audits and change control.
This role ensures that these critical processes are not only compliant with global and local GxP regulatory requirements (GCP, GVP, GEP, and others), but also consistently applied, scalable, and continuously improving across the organization.
As a key quality leader, the Senior Manager, Quality provides direction and oversight to Quality Managers responsible for the execution of QMS processes, ensuring high standards of performance, accountability, and consistency across teams and projects.
The role also plays a pivotal part in supporting organizational growth and integration, ensuring that quality processes remain robust, harmonized, and effective across newly integrated teams, systems, and ways of working.

Responsibilities

The responsibilities for the Senior Manager, Quality include, but are not limited to, the following:
QMS Process Management

• Oversees and leads the end-to-end execution and continuous improvement of core QMS processes, including:
  1. Deviations/Non-compliances
  2. Corrective and Preventive Actions (CAPA)
  3.  Risk Management
  4. Change Control
• Ensures these processes are:
  1. Applied consistently across teams, functions, and projects
  2. Efficient, risk-based, and aligned with regulatory expectations
  3. Designed to enable high-quality, inspection-ready outcomes

Quality Metrics and Monitoring

• Defines, implements, and monitors key quality metrics related to deviations, CAPA effectiveness, risk trends, and change management
• Translates data into actionable insights, identifying emerging risks, systemic issues, and improvement opportunities
• Drives data-informed decision-making to enhance QMS performance and maturity

Team Leadership

• Acts as line manager for Quality Managers, providing clear direction, coaching, and performance management
• Builds a high-performing team by developing capabilities, accountability, and ownership
• Ensures consistent and high-quality operational management of deviations, CAPA, risk management, and change control processes
• Promotes a strong culture of quality, continuous improvement, and collaboration across teams

Inspection Readiness

• Ensures that QMS processes under responsibility remain consistently inspection-ready
• Leads and hosts client audits and regulatory inspections, acting as subject matter expert for quality system processes
• Supports and/or conducts internal and vendor audits while ensuring timely and effective follow-up of audit observations and CAPAs
• Ensures processes are robust, traceable, and aligned with regulatory expectations

Audit and Quality Oversight 

• Plans and conducts internal and vendor audits, ensuring compliance with applicable GxP standards and company requirements
• Supports the qualification and oversight of vendors and partners, including audit execution and follow-up activities
• Evaluates audit outcomes, identifies systemic risks, and drives corrective and preventive actions
• Ensures effective tracking, closure, and reporting of audit findings and related actions

Business Support and Due Diligence

• Contributes to business development and client engagement activities by:
• Supporting company qualification questionnaires and client assessments
• Participating in due diligence activities and quality evaluations
• Providing input on quality capabilities, processes, and compliance frameworks

Integration Support

• Leads and supports the integration of newly acquired or merged organizations into the company QMS framework
• Ensures deviations, risks, and change controls related to integration activities are proactively identified, documented, and effectively managed
• Conducts and supports risk assessments, defining practical mitigation strategies during integration initiatives
• Drives harmonization and standardization of quality processes across diverse teams and operating models

Continuous Improvement

• Identifies and leads initiatives to improve efficiency, scalability, and effectiveness of QMS processes
• Collaborates with operational teams and cross-functional stakeholders to strengthen quality practices
• Drives process optimization and supports the ongoing evolution of the organization’s quality framework  

Experience - the ideal ca