Associate Director Regulatory Compliance R&D - Technology IT at Signant Health

• The Associate Director, Technology Regulatory Compliance serves as the technical compliance expert who translates quality and regulatory requirements into validated, compliant technical solutions. This role owns the technical implementation of compliance requirements across R&D, IT, Cloud Operations, and Information Security, executing Computer System Validation (CSV), Computer Software Assurance (CSA), and GAMP 5-based technical assessments. Working in partnership with the Quality Business Partner (who defines what needs to be compliant and why), this role focuses on how to implement compliant solutions technically, ensuring technical audit readiness and maintaining compliance through change control, technical documentation, and Centre of Enablement operations.

As part of our team, your primary responsibilities will be:

Technical Validation & Implementation

• Execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across technology systems.
• Perform GAMP 5 categorization and technical risk assessments for systems and applications.
• Create and maintain technical compliance documentation including Validation Plans/VSRs, Test Plans/Reports, Risk Mitigation documents, and Traceability Matrices.
• Execute technical evaluation and testing for Change Control processes.
• Implement risk-based validation approaches aligned with GAMP 5 principles and emerging regulatory frameworks.
• Translate quality requirements (received from Quality Business Partner) into technical validation strategies and test plans.

System Compliance & Technical Controls

• Implement and maintain FDA 21 CFR Part 11 and EU GMP Annex 11 technical controls across R&D, IT, Cloud Operations, and Information Security.
• Ensure technical audit readiness through system demonstrations, technical evidence gathering, and compliance documentation.
• Monitor infrastructure compliance for Database-as-a-Service (DBaaS) and Cloud Operations environments.
• Integrate quality requirements into technical system architectures and implementations.
• Maintain technical controls for electronic records, electronic signatures, audit trails, and system security.
• Coordinate technical aspects of customer audits, demonstrating technical compliance and providing evidence.

Centres of Enablement Operations

• Lead Testing Centre operations: Define technical testing frameworks, execute validation testing, implement test automation, and coach technology teams on testing best practices.
• Lead Compliance Centre operations: Define technical compliance processes, automate compliance workflows, and coach teams on compliance execution.
• Interpret Signant Health policies and translate them into technical implementation guidance.
• Define and harmonize SOPs across technology groups (R&D, IT, Cloud Operations, Information Security).
• Provide cross-technology group technical compliance support and subject matter expertise.
• Build technical compliance capabilities across technology teams through coaching and knowledge transfer.

Compliance Monitoring & Audit Support

• Design and execute technical audit procedures to assess compliance with policies, SOPs, and regulatory requirements.
• Conduct technical compliance assessments and testing across technology systems.
• Coordinate and represent technology teams in third-party audits, providing technical demonstrations and evidence.
• Recommend technical solutions and improvements to address audit findings and customer requests.
• Manage technical aspects of ISO 27001 implementation in collaboration with Legal, Regulatory and Compliance.
• Escalate technical compliance issues to Quality Business Partner for risk evaluation when appropriate.

Communication & Collaboration

• Develop technical training materials and tools to communicate compliance implementation requirements to technology teams.
• Receive compliance requirements from Quality Business Partner and translate into technical implementation plans.
• Collaborate with technology teams to ensure compliant technical solutions meet business objectives.
• Prepare technical compliance reports for senior management, regulators, and stakeholders.
• Partner with Quality Business Partner on customer audits (Quality leads strategy, Technology demonstrates technical compliance).
• Work with global compliance colleagues and cross-functional teams (Legal, IT, Cloud Operations, Information Security).

What You'll Bring:

Essential:

Formal Education & Certification

• Bachelor degree in Computer Science, Engineering, Life Sciences, or related technical discipline.
• Minimum of 5 years of experience in technical compliance roles within regulated environments, preferably in healthcare or life sciences.

Required Knowledge & Experience

• Deep knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies.
• Expertise in GAMP 5 principles, categorization, and risk-based validation approaches.
• Strong understanding of FDA 21 CFR Part 11, EU GMP Annex 11, and related technical compliance requirements.
• Experience implementing technical controls for electronic records, electronic signatures, and audit trails.
• Proficiency in creating validation documentation (VPs, VSRs, test plans, traceability matrices, risk assessments).
• Experience with cloud infrastructure compliance, DevOps, and modern software development practices.
• Knowledge of IT governance, risk management, and compliance frameworks (ISO 27001, SOC 2).
• Experience executing technical aspects of regulatory audits and inspections.
• Ability to translate regulatory requirements into practical technical implementations.

Preferred Qualifications

• Certifications in quality or compliance (ASQ CQE, GAMP certification, CISSP, or similar).
• Experience with test automation frameworks and compliance automation tools.
• Familiarity with Agile/DevOps validation approaches and continuous validation concepts.
• Knowledge of ICH E6(R3) and emerging regulatory frameworks for clinical trial technology.
• Experience implementing validation for cloud-native architectures and SaaS platforms.
• Background in software development, infrastructure, or database administration.
• Experience coaching and mentoring technical teams on compliance practices.

Personal Attributes

• Strong technical acumen with ability to understand complex system architectures.
• Excellent written and oral communication skills for diverse stakeholders including senior management.
• Strategic thinker who can balance compliance requirements with technical feasibility and business objectives.
• Proven project management skills from inception to completion.
• Detail-oriented with strong analytical and problem-solving abilities.
• Collaborative approach to working across technology and quality functions.
• Ability to coach and develop technical compliance capabilities in others.
• Adaptable to evolving regulatory landscape and emerging technologies.