Senior Director BIS Quality

2 weeks ago

Boston, United States argenx SE Full time

As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality. The Senior Director BIS Quality is responsible for both the strategic direction as well as the day-to-day operations and coordination of all activities relating to the argenx Computer Systems Assurance (CSA) Process. This includes GxP systems, Regulated systems and non-GxP systems. This covers the entire life cycle of our systems and ranges from Initial Impact Assessment, through initial implementation, on-going/agile enhancements, managing Saas Release assessment and remediation, and solution retirement. Key Accountabilities/Responsibilities The position will have the following key responsibilities: * Create a vision for BIS Quality that ensures the tools deployed by the BIS team deliver on their intended business value. * Focus the BIS-Q strategy on assuring Quality and Patient Safety vs mere Compliance. * Create a BIS-Quality framework that includes policies, procedures and instructions to support the entire argenx business. * Ensure this framework and its components are fully aligned with the latest guidance from EMA/FDA/PDMA. * Adopt a risk-adjusted approach to all BIS-Q activities. * Liaise with the Computer Systems team in the QA function. * Identify and manage our external CSV/A partners. * Lead a small internal team, augmented by consultants, to ensure all daily activities are carried out on time and with the highest levels of quality. * Liase with the appropriate BIS functions to perform the original CSA assessment, final implementation validation, AND define release management strategy for each platform. * Monitor and ensure successful completion of Release Management of all argenx platforms/solutions. * Monitor and ensure successful scheduling, execution and completion of all Periodic Reviews. * Partner closely with the Lega/Compliance function at argenx for alignment with GDPR, HIPAA, and APPI guidelines as well as with Finance to ensure SOX, and others as needed. Desired Skills and Experience * Minimum of 15 years working either in or near a biopharmaceutical medical or development sciences function, either within BIS/IT and/or in a development sciences function. * Excellent Communication and Leadership skills to both create a vision and enroll all elements of the organization. * Awareness of current regulations, draft and future directions, and Good Computing Standards. * Understanding of the shift from CSV to CSA and the new GAMP5v2 guidelines. * Experience as Assurance/Validation lead for computer systems in a regulated industry. * Understanding of the industry landscape and global regulatory requirements (e.g. GxP, HIPAA. GDPR, APPI, SOX etc..). * Strong understanding of ITIL standards. * Familiarity with the speed and nimbleness of non-GxP systems assurance. * Excellent attention to detail and documentation. * Demonstrated ability to work effectively with others, communicate, and influence at multiple levels within multidisciplinary organization. * Ability to exceed in a non-hierarchal environment. * Demonstrated ability to manage external service providers and budgets. * Demonstrated ability to monitor many project release schedules. * Adeptness in anticipating potential areas of extra focus as identified during the CSIA phase. Offer * A competitive salary package with benefits. * A work environment in a human-sized, dynamic, rapidly growing biotech company. #LI-onsite

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