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Senior Manager, Systems Validation and IT Compliance

Company: Aurinia Pharmaceuticals Inc.
Location: Rockville
Posted on: January 15, 2022

Job Description:

Our MissionAurinia exists to make a difference in transforming people's lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we've applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients' health. In addition to driving adoption of our approved therapy, LUPKYNIS---, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
Job DescriptionAurinia's Senior Manager, Systems Validation and IT Compliance will have responsibility for executing processes and procedures to assure the compliance and quality of IT systems and solutions. The position will provide project and quality leadership for regulated and critical business systems to ensure compliance with all applicable regulatory and operational requirements. The Senior Manager, working closely with the Quality team, will act as the liaison between IT and the applicable functional business departments to ensure understanding of operational compliance requirements and to establish how the IT projects meets those requirements.The position will apply knowledge of information system development, applicable regulations and business operations as well as IT policies, procedures and job aids in reviewing and approving quality plans, computerized systems validation, testing activities 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. They will ensure compliance with internal procedures, maintain records and provide quality and compliance oversight to IT delivery and change management processes across the company.
The Senior Manager will also support Project Management and Computer Systems Validation (CSV) activities by preparing/reviewing project documentation, test protocols/records, and verifying that appropriate procedures and quality standards are followed for system release.
Primary Responsibilities:
--- Assess the compliance of and validate new and existing GxP computerized systems per FDA regulations, EMEA Regulations, company policies and SOP's.--- Liaise with business groups to understand how they use IT systems in order to recommend whether systems should be included within the scope of various compliance areas (FDA, Privacy, ICH, HIPAA, etc.)--- Author and/or review all IT computerized system validation (CSV) policies and SOP's, obtaining input from Quality Assurance, Regulatory, Information Technology and applicable department leads.--- Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to:o Validation Master Planso Validation Risk Assessmentso Validation Project Planso User/Functional Requirement/Design/Configuration Specificationso Qualification Protocolso Validation Final Report, and Change Controlso Compliance Reviews--- Participate on and/or lead local CSV and change management committees; coordinating approach and processes.--- Oversee testing and validation activities and assure quality of documentation--- Expedite implementation of computer systems by overcoming obstacles using a scientific, risk-based approach.--- Work with other stakeholders to design quality computer systems to interface connectivity with other key business IT solutions.--- Assist in preparation and support for internal and external audits and inspections; provide support for follow up/remediation actions as needed.--- Contribute to the identification of Key Performance Indicators (KPIs) and metrics for validation.--- Ensure test case failures or bugs are adequately investigated, tracked, and resolved.--- Ensure accuracy and completeness of Software Development Lifecycle records.--- Review executed acceptance, general system, stress and stability testing for completeness.--- Collaborate with business users and Business Analysts to define user requirements and functional design specifications.--- Review/audit and/or approve key validation deliverables and change management deliverables for computerized systems.--- Act as a single point of contact for CSV initiatives.--- Resolve issues related to the creation, pre-approval, execution, review and/or final approval of CSV documentation.--- Maintain departmental metrics for CSV projects and report status to management on a regular basis.--- Review system changes and releases to production, making recommendations for approval, as appropriate.--- Participate as Compliance Subject Matter and/or Technical Expert as required, including Supplier Audits.

Qualifications--- BS in Computer Science, Engineering or related discipline with a minimum of 5 years relevant industry experience.--- At least 10 years relevant work experience with 7 years' experience in an IT/IS organization with demonstrated skills in solution delivery, software quality assurance and testing.--- Leadership of computer system validation programs and projects, including development of risk-based validation strategies.--- Development and implementation of software quality assurance procedures, such as risk assessment, change control, vendor management, defect management, and configuration management.--- Delivery of training in software quality assurance and validation subjects--- Auditing software quality and validation practices.--- 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)--- Proven ability to provide quality technical guidance to culturally and technically diverse project teams.--- Excellent oral and written communication skills.
Skills/Abilities
--- Thorough 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 define, implement, and maintain project process guidance related to quality management, tailoring of project deliverables and organizational processes and communicating with the project team as needed.--- Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards.--- Knowledge of system performance testing and experience developing performance tests.--- Proficient in MS Office.--- General knowledge of COBIT, GAMP 4/5 and the Industry Standard Validation Best Practices.--- Ability to work in an action-oriented, and rapidly changing environment.--- Ability to make good and timely decisions that keep the organization moving forward.--- Propensity to take on new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm.--- Ability to plan and prioritize work to meet commitments aligned with organizational goals.--- Consistently able to achieve results, even under tough circumstances. Can problem solve and bounces back quickly after set-backs.--- Ability to build partnerships with the Quality organization and work collaboratively with others to meet shared objectives.--- Recognizes the value that different perspectives and cultures bring to the organization.--- Ability to exhibit confidence and professional diplomacy, while relating to people at all levels internally and externally.--- Strong written and verbal communication skills and the ability to listen to hear what is working and what needs to adaptation.
Additional InformationAll candidate information will be kept confidential according to EEO guidelines.

Keywords: Aurinia Pharmaceuticals Inc., Rockville , Senior Manager, Systems Validation and IT Compliance, IT / Software / Systems , Rockville, Maryland

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