Manager, IT Quality

JOB SUMMARY:

• Responsible for management and oversight of the BTS IT Validation Quality Management System, processes, and improvement. Specifically, responsible for BTS SQA Operations and GXP Inspection Readiness improvements.
• In addition, the role is key to driving a sustained culture of quality and compliance across BTS IT, ensuring management visibility of all key process performance measures and action plan progress.
• Provide consultation to Divisional and Corporate counterparts on leveraging and consolidating quality and compliance best practices solutions for competitive advantage.
• Assess, then train and educate the appropriate business and IT communities on quality, compliance and standardize best practice systems when appropriate.
• In conjunction with internal and external business and technology partners, lead in setting quality and compliance strategy and vision to meet business objectives.
• The role manages the daily operations and performance of the following BTS IT Quality and Compliance
• functions:
• Management of SQA Operational staff ensuring appropriate capacity, work assignment and
• performance monitoring of staff and service provider compliance roles in support of infrastructure projects and maintenance activities. Management Review and QS metrics management and reporting.
• Management and performance reporting of Quality Agreements with Divisions and Service Providers.

EDUCATION AND EXPERIENCE:

Education:

• Minimum 4-year degree and/or 8 years in a comparable role in IT or a quality function.

Experience/Training Required:

• Must have had prior experience with CAPA management, Quality System management, strong root cause analysis capabilities, ability to identify improvement opportunities, build business cases and drive improvement projects to resolution as agreed.
• Certifications from ASQ and experience with ISO9001 or ISO13485 are preferred.
• Familiarity with document management practices. Prior experience as an SQA or management of an operational team within an IT project environment.
• Experience with Software Lifecycle management, IT Change Management and Controls practices, reporting, and senior management-level engagement.
• Understanding of infrastructure-related frameworks, processes, and practices (e.g., ITIL, GAMP).
• Knowledge of traditional and cloud-based IT Infrastructure platforms / components like Infrastructure as Code (IaC), IaaS, SaaS, PaaS, AWS, etc.
• Candidates with additional Data Integrity and/or cloud-based platform-specific SQA experience will have an advantage in the selection process.