Validation & Equipment Compliance Manager
About us Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.
More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.
This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
This fosters a culture of reliability, transparency, and ethical behaviour at every level.
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are.
We believe our differences make us stronger.
We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Global Technical Operations plan and coordinate team activities and support issue resolution.
Ensure operational efficiency and safety of departments, facilities, and equipment by planning and overseeing required maintenance activities and implementing actions to minimize health and safety risks.
Propose necessary investments to maintain safety, compliance, and operational effectiveness.
Health, Safety define and implement CAPA plans resulting from audits and inspections.
Issue and maintain procedures within the area of responsibility.
Participate in self-inspections,
regulatory authority inspections, and customer audits.
Maintain and control the Validation Change Control Program for validated/qualified systems and the Validation Management System (VMS).
Review and approve the Validation Master Plan (VMP).
Act as SME for process validation topics, including process changes, cleaning validation, hold times, and analytical instrumentation qualification.
Deliver training on Validation, Qualification, and Change Management processes.
Drive continuous improvement initiatives aimed at streamlining validation processes and reducing non-value-added activities.
Provide leadership and guidance for validation-related CAPA activities.
Participate in Quality Risk Management activities, contributing to FMEAs and Risk Control Plans as Validation SME.
Location Parma Budgeted Salary Range The budgeted salary range approved for this role is between €****** and €****** .
This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.
Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.
This role is eligible to participate in an annual premio scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities.
Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business.
All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.
This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet.
This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
This fosters a culture of reliability, transparency, and ethical behaviour at every level.
As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are.
We believe our differences make us stronger.
We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Global Technical Operations plan and coordinate team activities and support issue resolution.
Ensure operational efficiency and safety of departments, facilities, and equipment by planning and overseeing required maintenance activities and implementing actions to minimize health and safety risks.
Propose necessary investments to maintain safety, compliance, and operational effectiveness.
Health, Safety define and implement CAPA plans resulting from audits and inspections.
Issue and maintain procedures within the area of responsibility.
Participate in self-inspections,
regulatory authority inspections, and customer audits.
Maintain and control the Validation Change Control Program for validated/qualified systems and the Validation Management System (VMS).
Review and approve the Validation Master Plan (VMP).
Act as SME for process validation topics, including process changes, cleaning validation, hold times, and analytical instrumentation qualification.
Deliver training on Validation, Qualification, and Change Management processes.
Drive continuous improvement initiatives aimed at streamlining validation processes and reducing non-value-added activities.
Provide leadership and guidance for validation-related CAPA activities.
Participate in Quality Risk Management activities, contributing to FMEAs and Risk Control Plans as Validation SME.
Location Parma Budgeted Salary Range The budgeted salary range approved for this role is between €****** and €****** .
This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.
Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.
This role is eligible to participate in an annual premio scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities.
Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business.
All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.
This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.