Senior Director BIS Quality

Found in: Jooble US O C2 - 3 weeks ago

Boston MA, United States Blackwomenintech 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.

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