Computerized Systems Validation (CSV) Manager
Position: Computerized Systems Validation Manager
The Computerized Systems Validation (CSV) Manager will have responsibility for managing ongoing efforts in CSV as well as drafting policies, procedures and processes with the guidance of a senior compliance expert to establish compliance and quality through a CSV framework. The manager will follow the established framework through the lifecycle of computerized systems deemed GxP, SOX or HIPAA regulated including, as necessary, planning, requirements, specification and design and verification. The position reports to the Senior Manager, Systems Validation and Information Technology Compliance.
The CSV Manager will be responsible for the on-going management of Change Control Program, including the weekly presentation refresh and Change Request review for the CSV role. The manager will be responsible for managing the CSV activities of the periodic Veeva Vault update, following the precedent of preceding updates.
THE CSV Manager will lead the creation of the following specification documents for Sucampo, including project planning and reporting:
Role Specification for QualityDocs
Role Specification for Adaptive Insights
Role Specification for Great Plains
The CSV Manager will be responsible for other CSV activities including CSV SME for compliant data migrations, SOX-compliant system change controls and performing an annual audit of User Account Requests.
The position will apply knowledge of information system development, applicable regulations, guidances and business operations as well as IT policies, procedures and job aids in drafting computerized systems validation, testing and system lifecycle documentation, as necessary. The position will also apply knowledge of computer systems lifecycle management, systems development, delivery methods, and change management to ensure conformance to internal policies and procedures and the quality of deliverables. The position will support Computer Systems Validation (CSV) activities by preparing/reviewing test protocols/records, and verifying that appropriate procedures and quality standards are followed for system release.
Major Duties and Responsibilities:
- Draft IT computerized system validation (CSV) policies and SOP's, obtaining guidance from Information Technology and applicable department leads
- Lead ongoing CSV-related programs
- Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to:
- Validation Master Plans
- Validation Risk Assessments
- Validation Project Plans
- User/Functional Requirement/Design/Configuration Specifications
- Qualification Protocols
- Validation Final Report, and Change Controls
- Compliance Reviews
- Oversee testing and validation activities and assure quality of documentation
- Review/audit and/or approve key validation deliverables and change management deliverables for computerized systems
- Understanding of the IT aspects of biopharmaceutical regulatory compliance
- Knowledge of the various regulatory requirements affecting IT systems used in the development and manufacture of biopharmaceutical products
- Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards
- Strong written and verbal communication skills and the ability to communicate effectively with people at all levels
- Excellent presentation, project management, problem-solving, training/coaching, and conflict resolution skills
- Proficient in MS Office, Visio and PowerPoint
- General knowledge of COBIT, GAMP 4/5 and the Industry Standard Validation Best Practices
- Ability to work in an action-oriented, fast-paced and rapidly changing environment
- BS in Computer Science, Engineering or related discipline with a minimum of 10 years relevant industry experience. Must Have.
- At least 10 years relevant work experience in an IT/IS organization with demonstrated skills in software quality assurance and testing. Must Have.
- Participation on computer system validation projects. Must Have.
- Performance of software quality assurance processes, such as risk assessment, change control, vendor management, defect management, and configuration management. Must Have.
- Delivery of training in software quality assurance and validation subjects. Desirable.
- Expertise in software quality assurance and validation regulations (e.g., US FDA, Eudralex), international guidelines (e.g., PIC/S, ICH, WHO), and industry standards (e.g., GAMP). Desirable.
- Excellent oral and written communication skills. Must Have.
- Minimal supervision required. Must Have.
LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions. LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations. The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects. LABANSWER IS HIRING!!! We hire full time consultants in all areas of Laboratory Informatics.
Below please find our philosophy statement to see if LabAnswer is a good fit for you:
ll business decisions will be made with acceptable profit margins in mind; however integrity, trust, honesty, and sound character will never be violated. While acknowledging the strengths of each individual, LabAnswer believes in the power of the team. It is this teamwork that makes exceptional solutions possible. We do not require perfection, but demand the pursuit of excellence. Every LabAnswer employee will deliver uncompromising, personalized, professional service to all our clients."
Tue, 3 Oct 2017 03:39:00 PDT