Quality Lead Global CSV (Computer System Validation)
Location: Colmar - Remote
The Quality Lead Global CSV plays a key role within the Quality Assurance organization, in close alignment with the IT /OT organization to ensure that the requirements for the qualification of computer infrastructure and validation of IT systems are clearly defined in policies, corporate quality standards, validation master plans, and standard operating procedures. The role is responsible to define qualification & validation strategies for IT/OT Infrastructure and systems, and services ensuring computerized systems comply with internal and external regulations and best practices in Pharma/Life Sciences GMP environment. Additionally, the role offers QA support to IT/OT CAPEX projects and engages with internal & external suppliers of infrastructure, applications & services to ensure compliance and high quality of service delivery.
The Quality Lead Global CSV will supervise a team of CSV specialists and lead the development, implementation, and maintenance of global CSV Governance. The role is responsible for developing policies and common approach to compliance of IT/OT infrastructure and systems with 21 CFR Part 11, EU GMP Annex 11, other regulatory guidance, and best industry practices.
What you will get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependent on role and location
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.
What you will do:
Ensure that the requirements for the qualification & validation are communicated effectively to IT/OT, QA and other relevant personnel, including system owners (IT) and process owners (Business), within the organization.
Lead the development of governance & guidance for the global computer systems quality and validation policies in cooperation with governance owners. Ensure that the requirements for the validation of global computerized systems are clearly defined in policies, corporate quality standards, VMPs, and standard operating procedures.
Ensure validation strategies are fit-for-purpose an based on risk management principles, taking into account intended use (GxP/non-GxP as well as Rx/CHN) of the software tool.
Ensure that these requirements are communicated effectively to IT/OT, QA and other relevant personnel, including system/process owners, within the organization. Work with other global quality personnel to develop official policies and common approaches to compliance with 21 CFR Part 11, EU GMP Annex 11, and other regulations, ensuring effective communication to all manufacturing sites.
Project QA for the validation of global GMP IT/OT infrastructure, applications and services within the organization. Act as responsible QA on global IT/OT projects as required. Consult and advise computer systems projects on the correct application of internal and external regulations.
Strategic support for IT/OT architecture initiatives to ensure GxP compliance and information quality across the organization.
Decision authority on standards relating to GMP for IT/OT systems (business, quality management, manufacturing, and laboratory) for software, hardware and networks that are developed and defined in order to enable effective and efficient validation activities to be carried out.
In conjunction with IT/OT and sites, evaluate new applications in order to identify validation requirements. In conjunction with IT/OT and sites, support the evaluation of new applications in the IT infrastructure area to identify qualification requirements.
What we are looking for:
MSc in IT, OT, (Bio-)Informatics, Engineering, or related technical discipline.
5 - 10 years relevant experience in both IT/Engineering and Quality / Compliance
Proven ability to coordinate cross-functional projects, with exposure to global technology transfers and site integration initiatives, as well as deep expertise in QA CSV, IT/OT systems validation, infrastructure design and operation, automation, lab systems, manufacturing systems data, and quality systems.
Demonstrated experience in leading teams of subject matter experts and managing QA responsibilities for validation documents, including changes, deviations, CAPA, SOP governance, and training programs.
Excellent verbal and written communication skills in English.
Willingness to travel (up to 10%).
There is no visa sponsorship available for this role
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.