Quality Process Senior Manager

About the role

The Quality Process Senior Manager designs, plans, coordinates and executes projects aimed at improving manufacturing quality on site. This role supports Process Quality and Quality Engineering, maintains regulatory‑compliant Quality Management Systems, and leads In‑Process Quality Engineers.

Key responsibilities

• Coordinate activities of Quality Engineering and In‑Process Quality Engineering teams.
• Support new product and process transfer projects, reviewing PFMEA and risk analyses.
• Plan and execute defect‑prevention projects and design process‑control strategies.
• Facilitate Quality Control supervision through Quality Engineers and Supervisors.
• Review and approve documents, investigations and regulatory submissions as an alternate Quality Management representative.
• Provide technical support and training on quality technologies across departments.
• Maintain subject‑matter expertise for multiple chapters of the quality system (e.g., CAPA, Process Validation, Traceability, Inspection).

Required profile

• Bachelor's or advanced degree in Engineering, Life Sciences or related field.
• Minimum 10 years of experience in Quality Assurance, Quality Systems or Manufacturing within a regulated industry.
• At least 3 years leading technical or quality teams.
• Strong knowledge of FDA regulations, ISO 13485 and ISO 11135.
• Proven experience with CAPA systems, validation, risk management and process controls.

Required skills

• FDA regulatory compliance
• ISO 13485 and ISO 11135 standards
• CAPA system management
• Process validation and risk management
• Process control strategies
• Sterility assurance and sterilization validation
• Microbiology‑based quality systems
• Lean and Six Sigma methodologies