cFocus Software seeks a Quality Manager / Risk Assessor to join our program supporting Housing and Urban Development (HUD). This position is remote. This position requires a Public Trust clearance. Qualifications: - Bachelor’s degree in Cybersecurity, Information Technology, Risk Management, or related field. - 7+ years of experience in cybersecurity, risk assessment, or quality assurance roles. - Experience supporting federal environments and compliance frameworks (NIST, FISMA, RMF). - Strong understanding of SOC operations, security controls, and risk management processes. Duties: - Develop, implement, and maintain Quality Assurance (QA) and Quality Control (QC) processes for SOC operations. - Establish and manage risk assessment methodologies aligned with NIST Risk Management Framework (RMF). - Identify, analyze, and mitigate cybersecurity risks across systems, cloud environments, and SOC operations. - Maintain and manage risk registers, POA&Ms (Plans of Action & Milestones), and remediation tracking. - Ensure compliance with federal standards including NIST SP 800-53, FISMA, CISA directives, and OMB mandates. - Conduct continuous monitoring and risk assessments of security controls and operational processes. - Support audit readiness, audit response, and compliance reporting activities. - Perform internal quality reviews and validation of SOC processes, tools, and deliverables. - Develop and track Key Performance Indicators (KPIs) and quality metrics for SOC performance. - Lead root cause analysis for incidents, deficiencies, and audit findings. - Coordinate with SOC teams, engineers, auditors, and leadership to improve quality and reduce risk. - Validate security controls, configurations, and processes against best practices and compliance requirements. - Support development and maintenance of the Security Operations Management Plan (SOMP). - Ensure proper documentation and reporting of risks, findings, and corrective actions. - Provide recommendations for process improvements and risk reduction strategies.

Establish and evolve enterprise delivery governance frameworks, provide independent assurance across programs, and lead automation of governance processes to enhance decision-making and risk management through data-driven insights.

Lead and facilitate industry roundtables, manage senior stakeholder relationships, and develop benchmarking frameworks to provide decision-relevant insights for financial institutions, ensuring structured discussions on emerging risks and regulatory...

• Lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. • Provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies. • Report to the Sr. Director of Process Validation within the Global MSAT organization and collaborate on overall validation strategy. • Provide strategic and scientific leadership for process validation across commercial programs. • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch. • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans. • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality. • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks. • Monitor and communicate risk trends and key risk indicators to stakeholders. • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state. • Contribute to lifecycle management activities, including process improvements and continued process verification. • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity. • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies. • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. • Support deviation investigations, ensuring timely resolution and sustained compliance. • Contribute to authoring and reviewing regulatory filings and responses to health authorities. • Effectively communicate the scientific and commercial rationale for validation and risk management strategies. • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. • Provide guidance on raw material qualification strategies to ensure supply reliability. • Support validation activities across internal and external manufacturing networks. • Communicate process validation performance and risk insights to key stakeholders. • Build strong working relationships and influence across a matrixed organization. • Contribute as a key member of the Global MSAT organization to enable successful commercialization. • Travel - 10-30% domestic and international travel required.