Digital Compliance Assurance Manager

Role Overview

• The Digital Compliance Assurance Manager is responsible for ensuring that digital platforms, scientific informatics systems, cloud solutions, and computerized systems implemented or supported by Zifo (or customer in case of customer engagements) meet applicable regulatory, quality, and data integrity requirements.
• The role partners with client stakeholders, quality organizations, IT teams, and project delivery teams to establish compliance frameworks, assess risks, support audits and inspections, and ensure adherence to regulations such as FDA 21 CFR Part 11, GxP, EU Annex 11, GAMP 5, ALCOA+ principles, and internal quality standards.
• This position serves as a trusted advisor to clients and internal teams, driving compliance-by-design practices across digital transformation initiatives and scientific informatics platforms.
• Digital Compliance Leadership
• Develop and maintain digital compliance strategies for laboratory, manufacturing, quality, and clinical systems.
• Ensure computerized systems are implemented and maintained in accordance with applicable regulatory requirements and industry best practices.
• Provide compliance oversight for cloud-based and on-premise scientific informatics solutions.
• Promote a culture of quality, compliance, and continuous improvement across projects and service engagements.
• Quality & Regulatory Compliance
• Interpret and apply regulatory requirements.
• Lead compliance assessments and gap analyses.
• Review and approve validation and compliance documentation.
• Ensure audit readiness and inspection preparedness.
• Support AI systems implementation & compliance.
• Computer System Validation (CSV) & Assurance
• Oversee and participate in validation lifecycle activities.
• Support adoption of risk-based Computer Software Assurance (CSA) approaches.
• Ensure compliance controls remain effective throughout the system lifecycle.
• Audit & Inspection Support
• Lead compliance reviews and supplier assessments.
• Support regulatory inspections and client audits.
• Investigate compliance findings and drive CAPA implementation.
• Governance & Risk Management
• Establish governance frameworks for digital systems and data management.
• Conduct periodic compliance and data integrity reviews.
• Evaluate risks associated with system changes, integrations, AI-enabled solutions, and emerging technologies.
• Client Consulting & Stakeholder Management
• Serve as a compliance SME on client engagements.
• Provide strategic guidance during digital transformation initiatives.
• Team Leadership
• Mentor validation, quality, and compliance consultants.
• Develop compliance standards, templates, and best practices.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, Information Systems, Quality Assurance, or related field.
• 10+ years of experience in regulated life sciences or scientific informatics environments.
• 5+ years of experience in compliance, validation, quality assurance, or computerized system governance.
• Strong knowledge of CSV, CSA, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
• Experience leading audits, inspections, and remediation programs.
• Master’s degree preferred.
• ASQ certifications (CQA, CQM) or equivalent.
• Experience with AI/ML governance and compliance frameworks.
• Consulting experience in scientific informatics and digital transformation.
• Regulatory Compliance Expertise
• Risk Assessment & Mitigation
• Client Relationship Management
• Leadership & Team Development
• Project & Program Management
• Communication & Influencing Skills
• Continuous Improvement Mindset

Tech Stack

• Cloud

Benefits

• CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies.
• We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.
• We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
• If you share these sentiments and are prepared for the atypical, then Zifo is your calling!
• Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.