Senior IT Compliance Manager
1 month ago
About the Company:
Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT.
Job Overview:
We are seeking an experienced Senior IT Compliance Manager to join our team. In this role, you will be responsible for managing and performing audits with a focus on Computer System Validation (CSV) audits.
Main Responsibilities:
- Support the audit process:
- Develop and maintain an adequate audit plan for global, regional, and local computerized systems and compliance processes.
- Select and manage qualified service providers for Global Quality, such as 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.
Additional Responsibilities:
- 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 those 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 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.
Requirements:
- 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.
Salary: The salary range for this position is approximately £80,000 - £110,000 per annum, depending on experience.
Location: This role can be based in either Windsor, UK or Frankfurt, DE.
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