Our Mission & Strategy

Aurinia 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.

Aurinia’s Senior Manager, Systems Assurance and IT Compliance will have responsibility for executing and managing processes and procedures to assure the continued compliance and quality of IT systems and solutions. The position will provide project leadership for regulated and critical business systems to ensure compliance with applicable processes and operational requirements in support of established regulations. Working closely with the Senior Manager, Quality Assurance – Computer Systems, will act as the liaison between IT, Quality, and the applicable functional business departments to ensure a risk-based understanding of system validation and operational compliance requirements and to help ensure IT projects meets those requirements.

The position will apply experience of vendor assessment, information system configuration and customization, software validation and assurance, and business operations as well as policies, procedures and job aids in creating and reviewing quality plans, computerized systems validation/assurance, 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 and audit readiness. They will ensure systems and process compliance with internal procedures, maintain records, and provide assurance 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 / Software Assurance (CSV/CSA) activities by preparing/reviewing project documentation, test protocols/records, and verifying that appropriate procedures and quality standards are followed for system release and enhancement.

Primary Responsibilities:

• Review and assess the compliance of and support the assurance of new and existing GxP computerized systems per FDA regulations, EMEA Regulations, and company policies and SOP's.
• Liaise with business groups to assess and understand how they use IT systems to recommend applicability of various compliance and regulatory areas (FDA, Privacy, ICH, HIPAA, etc.)
• Process Manager for all IT computerized system validation/software assurance (CSV/CSA) policies and SOP's, obtaining input from Quality Assurance, Regulatory, Information Technology and applicable department leads.
• Develop, review, and support appropriate testing strategies and standards and provide input on all CSV/CSA 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,
  • Change Controls, and
  • Periodic Reviews
• Participate on and/or lead local CSV/CSA and change management committees, coordinating approach and processes.
• Manage testing and validation activities and assure quality of documentation
• Champion a risk-based approach for agile cloud-based systems implementation and lifecycle strategy supporting system validation and assurance 
• 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), Key Risk Indicators (KRIs) and metrics for validation/assurance processes.
• Ensure accuracy and completeness of Application and System Lifecycle records.
• Collaborate with business users and Business Analysts to define user requirements and functional design specifications supporting software assurance and compliance.
• Review/audit key validation deliverables and change management deliverables for computerized systems.
• Act as a single point of contact for CSV/CSA initiatives.
• Resolve issues related to the creation, pre-approval, execution, review and/or final approval of CSV/CSA documentation.
• Maintain departmental metrics for CSV/CSA projects and report status to management on a regular basis.
• Review and provide a risk-based approach to system changes and major releases to production, making recommendations for approval, as appropriate.
• Participate as Subject Matter Expert as required, including Supplier Audits.

• 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 assurance and testing, and vendor assessment.
• Leadership of computer system validation/assurance projects, including development of risk-based validation strategies.
• Development and implementation of software assurance procedures, such as risk assessment, change control, vendor management, , and configuration management.
• Delivery of training in software assurance and validation subjects
• Auditing software assurance and validation practices.
• Expertise in software 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 (English).

 Skills/Abilities

• Thorough understanding of the IT aspects of biopharmaceutical regulatory compliance.
• Knowledge of the implementation of 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 software assurance, 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 and process 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 growing environment.
• 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, project, and operational goals.
• Consistently able to achieve results, even under tough circumstances; Can problem solve and bounces back quickly after setbacks.
• Ability to maintain relationships with the Quality organization and work collaboratively with other business areas 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.

All candidate information will be kept confidential according to EEO guidelines.