What We Do:

Florence (florencehc.com) software reduces the time it takes to deliver medical cures to those who need them. Our industry-leading software is used to streamline clinical trials at over 10,000 research sites, sponsors, and CROs across 44 countries.

Florence was recognized as the Biggest Impact Company, a Top 10 Innovative Company in Georgia by the Technology Association of Georgia in 2021, and most recently No. 31 on the Fortune list of Best Small Workplaces 2021.

What You’ll Bring to The Team:

The Florence Compliance Team is looking for a subject matter expert (SME) on computer systems and the software development cycle (SDLC) who is passionate about clinical trials to advance cures. To be successful, you must be comfortable with streamlining processes, educating others, and challenging the status quo in a regulated yet continuously evolving and innovative environment. This role serves as Florence’s SDLC SME during audits and is responsible for training the Florence Product, Development, and Software Quality Assurance (QA) Teams on the technical aspects of their regulated duties.

You will: 

• SDLC-Compliance Liaison: Partner closely with the Florence SDLC Teams (Product, Software Quality Assurance (QA), and Development) to gain knowledge of the current procedures as well as educate and communicate compliance requirements of computer system validation CSV) and documentation 
• Software Audit SME: Serve as the software (SDLC/validation) subject matter expert (SME) during audits and regulatory inspections; prepare and recommend remediation plans as part of internal and/or external audits
• Software Documentation Compliance: Ensure deployment-specific validation records are maintained (e.g., User Requirements Specifications, Validation Plan, Risk Assessment, Test Protocols/Reports, Validation Summary Report, etc.); as needed, investigate discrepancies and facilitate incident/deviation management
• Global Regulatory/Technical Review: Collaborate with our Global Regulatory Specialist and data protection teams to identify potential software/technical requirements of any regulatory interpretations for US FDA 21 CFR Part 11, EU EMA, and UK MHRA as well as EU GDPR, UK GDPR, and US HIPAA/CCPA; communicate technical requirements to the necessary SDLC teams for design and implementation
• SDLC Evidence Inventory: Ensure Florence’s audit evidence inventory is mapped to its regulatory requirements and controls and up-to-date
• SDLC Audit Readiness Automation: Explore manual and/or redundant SDLC documentation or evidence generation workflows suitable for automation with software tools
• Improvement Projects: Collaborate with the Florence Compliance Team on various projects to improve and innovate technical documentation for audit readiness

An Ideal Candidate has:

• 3+ years of relevant experience in software validation and change management on an SDLC team, preferably in a regulated industry (e.g., pharmaceutical, medical device)
• Fluency in the software development life cycle (SDLC), quality management systems (QMS), and classic validation documentation
• Audit-minded and working knowledge of FDA Software Validation Guidelines and Good Documentation Practices (GDP)
• Interested in continuous improvement and ways to minimize redundancy
• Comfortable working independently, challenging the status quo, and meeting deadlines
• Plus: Awareness of security (SOC and ISO) and privacy (GDPR, HIPAA)

What’s in it for you?

• Work with the best: The Florence team is composed of document management, clinical trials, and software security experts as well as doctors and Ironman triathletes. Get on board, learn from and work with the best.
• Make the leap: Join our high-output culture to create innovative, modern, and purposeful software solutions.
• Do well: We offer a competitive compensation package, medical and dental insurance, and office space in the heart of the city.

Florence Healthcare supports workplace diversity and does not discriminate on the basis of race, color, religion, gender identity or expression, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, physical disability, or any other protected class.