Quality & Compliance Manager
Overview In this role, you will lead Global Quality Operations to harmonize quality across manufacturing sites and laboratories. You will drive continuous improvement, oversee quality topics, and ensure compliance with GMP and regulatory standards. You will collaborate with site Quality Directors and Compliance teams to align processes and prepare for inspections. This position offers leadership scope across multiple sites from Parma, with a focus on building a culture of quality excellence and cross-site coordination.
Retribuzione / Benefits
company car
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
Responsabilità
Oversee and harmonize quality operations across all sites to ensure product quality and adherence to Quality KPIs
Establish and enforce validation guidelines for systems and processes per GMP regulations
Supervise validation processes, draft and review Validation Project Plans and Final Reports, set timelines, and coordinate corrective actions
Coordinate cross-site quality efforts with site Quality Directors,
support business continuity assessments, and facilitate Corporate/Local Quality Council activities
Collaborate with Compliance to meet internal and regulatory requirements and prepare for inspections
Provide strategic leadership to foster a culture of quality excellence across the organization
Requisiti fondamentali
Degree in scientific disciplines
Minimum 15 years of pharmaceutical quality assurance experience with at least 10 years in a leadership role
Deep understanding of quality management systems, compliance standards, and regulatory requirements (EMA, FDA, etc.)
Experience with EU, US, and rest of world regulatory authorities
Strong leadership and people management
Excellent communication and relationship-building skills
Strategic thinking and ability to influence cross-functional teams
Quality management systems (QMS) expertise
GMP regulatory requirements and inspections experience
Validation governance, validation project planning and reports
Retribuzione / Benefits
company car
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
Responsabilità
Oversee and harmonize quality operations across all sites to ensure product quality and adherence to Quality KPIs
Establish and enforce validation guidelines for systems and processes per GMP regulations
Supervise validation processes, draft and review Validation Project Plans and Final Reports, set timelines, and coordinate corrective actions
Coordinate cross-site quality efforts with site Quality Directors,
support business continuity assessments, and facilitate Corporate/Local Quality Council activities
Collaborate with Compliance to meet internal and regulatory requirements and prepare for inspections
Provide strategic leadership to foster a culture of quality excellence across the organization
Requisiti fondamentali
Degree in scientific disciplines
Minimum 15 years of pharmaceutical quality assurance experience with at least 10 years in a leadership role
Deep understanding of quality management systems, compliance standards, and regulatory requirements (EMA, FDA, etc.)
Experience with EU, US, and rest of world regulatory authorities
Strong leadership and people management
Excellent communication and relationship-building skills
Strategic thinking and ability to influence cross-functional teams
Quality management systems (QMS) expertise
GMP regulatory requirements and inspections experience
Validation governance, validation project planning and reports