Senior IT Compliance Analyst

JOB DESCRIPTION:

The Senior IT Compliance Analyst supports the infrastructure function as Senior IT Compliance Analyst for the qualification of traditional, digital, and cloud-based IT infrastructure components and platforms. Develops, implements, and supports infrastructure qualification and change control processes.  Supports inspection requests for infrastructure and collaborates across the operational teams and other IT Compliance Analysts to ensure evidence meets the request requirements.

• Support the operational team to plan and execute the Qualification of IT Infrastructure components (traditional and cloud-based platforms/components) and validate the associated software/tools used.
• Provide quality review and approval of deliverables in compliance with BTS SLC.
• Provide data quality and integrity subject matter expertise.
• Provide back-end audit/inspection support.
• Develop/enhance the policies, processes, procedures, and templates/guidelines. Identify process improvement opportunities and execute continuous improvement projects through Lean / Six Sigma methodologies.
• Drives the GXP Inspection Support and defends the infrastructure validation strategies to internal auditors, regulatory authorities, and other certified bodies
• Collaborates with the infrastructure team to build compliance capabilities to assure the quality of the deliverables and to ensure business needs are met.
• The role must be familiar with Quality Risk Management principles and practices to guide teams and management with risk-based decision-making capabilities.
• The role must be familiar with Good Documentation Practices and assist as appropriate with required documentation for compliance purposes.
• The role reports to the US manager of IT Compliance Operations and is within the Strategy, Planning, International Operations & Compliance function of BTS IT.
• The role works with the various levels of the BTS Infrastructure organization to ensure compliance and drive compliance improvements in BTS Infrastructure.
• The role works closely with peers of BTS SQA and BTS Infrastructure to sustain a quality mindset within the IT organization.
• The position is accountable to review all phases of the SLC activities in infrastructure (including applications used there). Acts as an SLC mentor to Infrastructure technologists.

EDUCATION AND EXPERIENCE:

Education:

• Bachelor’s Degree in Computer Science or equivalent or Information Technology or equivalent plus 7+ years of related work experience with IT Quality in the infrastructure of the life science industry, or an equivalent combination of education and work experience.
• Certifications from ASQ and in ISO9001 or ISO13485 are preferred.

Experience/Training Required:

• Strong knowledge of GXP regulations and infrastructure and software validation principles.
• Familiarity with quality risk management principles and tools such as FMEA.
• Understanding of infrastructure-related frameworks, processes, and practices (e.g., ITIL, GAMP)
• Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner.
• Highly self-motivated, goal orientated, and self-directed.
• Demonstrated ability to operate and innovate in a small team with a fast‐paced environment, balancing both strategic and tactical needs.
• Experience in automated testing and execution of qualification/validation protocols is required, review/approval experience of SLC deliverables is preferred
• Flexibility to adapt to changing assignments and ability to effectively prioritize efforts
• Effective with written and verbal in English communications at all levels.
• The role must maintain compliance expertise and be effective at applying requirements into the IT and business environment that supports business goals and maintains a compliant state.
• Knowledge of traditional and cloud-based IT Infrastructure platforms/components like Infrastructure as a code (IaaC), 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.