Manager, IT Assurance, Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the enterprise IT Quality Systems Assurance and Compliance program, encompassing both internal and external audits.

• Analyze and implement government regulations and standards within the IT Quality Management System.

• Recognize, escalate, and mitigate IT compliance risks.

• Deliver compliance training and support to global IT and business teams.

• Develop, update, and manage Standard Operating Procedures (SOPs).

• Organize and assist with internal and external audits, regulatory inspections, and corrective action plans.

• Keep audit documentation up to date and ensure prompt resolution of non-conformances.

• Enhance audit preparedness and monitoring via reporting and analytics tools.

• Ensure that computer systems are validated and managed in accordance with regulatory standards.

• Lead scalable IT assurance procedures while overseeing lifecycle and test management tools.

• Maintain computerized systems in a validated state through change control processes, system inventory, and regular reviews.

• Support automation initiatives that enhance the effectiveness of quality systems.

• Identify opportunities for process improvements, automation, analytics, and testing.

• Collaborate with IT and business stakeholders to develop quality and compliance solutions.

• Guide, mentor, and nurture the IT assurance and compliance team members.

• Propel large projects to successful completion.

• Assist department leadership with compliance-related data.

• Provide expertise in IT supplier quality vendor audits.

• Work with vendors to evaluate software tools and services.

• Conduct training sessions on test management tools and compliance best practices.

⛳️ Requirements

• Must be at least 18 years old.

• A Bachelor’s degree in sciences, engineering, IT, or a related technical field is required; a combination of education and relevant experience may be accepted in lieu of the required education.

• A minimum of 10 years of direct experience in IT quality assurance, compliance, and regulatory settings.

• Familiarity with FDA inspections, notified body audits, and global/multi-site quality systems.

• Proven experience in managing team objectives, fostering growth, and coordinating weekly activities.

• Practical experience with software validation/testing in regulated environments.

• Experience in managing and implementing lifecycle and test management tools.

• Background in Scrum/Agile methodologies and working with systems integrations/data migration.

• In-depth knowledge of IT quality and regulatory standards, including 21 CFR, Annex 11, SOX, PCI, and ISO 13485.

• Advanced comprehension of computer software assurance, systems validation, risk-based validation methodologies (GAMP 5), and good documentation practices (GDocP).

• Experience leading internal and external audit initiatives.

• Proficient in Word, PowerPoint, Excel, Visio, eQMS, and Smartsheet.

• Capability to develop and implement global standard operating procedures.

• Hands-on experience with test management tools, automation tools/scripts, APIs, and data conversion testing/automation is strongly preferred.

• Experience with automation, AI, or generative AI tools is highly desirable.

• Knowledge of responsible AI practices is also highly desired.

🏝️ Benefits

• Flexible remote work arrangement.

• Travel requirements are typically less than 10%.