As a member of the IT Quality & Regulatory Compliance team, the Lead IT Analyst Regulatory Compliance helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems.
PRINCIPAL DUTIES & RESPONSIBILITIES:
• Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is
• captured and reported to support validation activities.
• Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities.
• Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations.
• Provide guidance, training, and support to IT personnel in their validation efforts, to ensure compliance.
• Provide quality assurance oversight for system related issues (deviations, incidents, etc.)
• Assist in the development of IT Controls.
• Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
JOB DEMANDS:
• This job requires the Quality Assurance and Validation Specialist to attend department and user meetings, system assessment meetings, trainings, and other essential tasks.
• The Quality Assurance and Validation Specialist must maintain a professional manner in representing the company and in working with its agents and associates.
• The Quality Assurance and Validation Specialist should demonstrate initiative and self-direction while also knowing when to seek assistance.
• This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
JOB IMPACT:
• The Quality Assurance and Validation Specialist’s role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.
QUALIFICATIONS:
• Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines.
• Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL.
• Excellent communication skills, both verbal and written.
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
• Knowledge of general software and database concepts.
• Experience with risk analysis and risk management practices and tools.
• Knowledge of infrastructure technology and platforms.
• The ability to work both independently and with teams at various levels in the organization.
• Excellent organizational skills and attention to detail and accuracy.
• Five or more years of experience in computerized system validation within a regulated environment