Sr. Manager, Computer System Validations & Audits (Windsor, UK or Frankfurt, DE)

Job title:

Sr. Manager, Computer System Validations & Audits (Windsor, UK or Frankfurt, DE)

Company

Job description

Otsuka Pharmaceutical Europe is proud to be an equal opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all Employees. All qualified applicants will receive consideration for employment regardless of their race, color, religion, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or any other protected status.Otsuka Pharmaceutical Europe is committed to ensuring our hiring process is accessible to everyone. Should you require any accommodation or adjustments during the application or interview process, please do not hesitate to let us know.About the job:The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits.Additional tasks are to support the continuous improvement of the Otsuka Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, and the project liaison activities.

• KEY RESPONSIBILITIES

In close collaboration with the Head of Global Quality Management of GCP, CSV GVP, Senior Director Global Quality Management and the CSV Audit Lead:Support the audit process:

• Develop, maintain and provide input to an adequate audit plan for global, regional and local, computerized systems and compliance processes
• Select and manage qualified service providers for Global Quality, e.g., contract auditors.
• Manage audits and contract auditors in line with the audit plan, Otsuka’s business model and applicable procedures
• Plan, supervise, conduct, and support internal and external GxP audits
• Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
• Maintain a tracking tool for audits, findings and corrective and preventive actions
• Provide input for the development and maintenance of the audit tracking tool

Support inspections:

• Coordinate/Support the preparation for GxP inspections
• Coordinate/Support the responses to Regulatory Authorities
• Supervise and provide input to the corrective and preventive actions
• Follow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional Areas
• Maintain a tracking tool for inspections, findings and corrective and preventive actions.

Support the development, implementation, continuous improvement and documentation of Otsuka Companies’ Quality System

• Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
• Cover GxP related Functional Areas, specifically thus related to CSV.
• Collaborate with the respective Functional Area Heads
• Collaborate with the respective Global and Regional Quality Leads and functions
• Foster a continuous improvement mentality within Otsuka
• Ensure the establishment and maintenance of the required Quality documentation and ensure appropriate quality standards are adhered to in the management of this documentation
• Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
• Manage planned and unplanned deviations reported by the Functional Areas and support them by resolving the deviations.
• Develop and support global compliance training procedures in collaboration with other Otsuka companies and provide training in the area of expertise as assigned.

Support Regulatory Intelligence

• Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of Otsuka’s procedures.
• Evaluate impact of regulatory changes for the Otsuka Quality System, in particular related to IT Compliance, CSV Data Integrity
• Ensure information sharing and action taking
• Enable Otsuka to maintain the Quality System in a compliant state with a changing regulatory environment
• Recognised industry committee participation

Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs)

• Ensure SOPs/ WPs are compliant with applicable requirements and regulations
• Ensure SOPs/ WPs mirror the actual Otsuka company processes by working with process subject matter experts and key stakeholders

Support the validated state of computerised systems

• Provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)
• Provide quality related input and guidance for computerised system validation activities such as risk and GxP applicability
• Supervise and provide input to the corrective and preventive actions
• Follow-up on the development, implementation and completion of corrective and preventive actions with the Functional Areas
• Ensure that relevant validation and technical/ IT-infrastructure/ data integrity activities comply with applicable global, regional and local compliance requirements and are documented accordingly
• Liaise and collaborate with validation and IT experts

Provide advice and act as project liaison

• Provide sound advice and interpretations related to current GxP guidelines and regulations on CSV Data Integrity to Senior Management and Otsuka employees
• Be accountable for quality-related input in decision making processes with relevance for GxP compliance
• Act as quality liaison for assigned projects
• Additional Job Description

Additional Job DescriptionQUALIFICATIONS/ EXPERIENCE REQUIRED

• Degree in natural science or equivalent business experience
• Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data Integrity
• Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance
• Experience as a Lead Auditor on internal audits and external vendor audits.
• Experienced in GxP related CSV audits and inspections
• Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development
• Understanding of computer hardware and network/infrastructure requirements

We Offer:

• Competitive salary and comprehensive benefits package.
• Flexible working practice and remote work opportunities.
• A collaborative and supportive work environment.
• Opportunities for professional development and growth in an inclusive and equitable workplace.

Expected salary

Location

Windsor, Berkshire

Job date

Mon, 25 Nov 2024 05:45:11 GMT

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