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Found 37 Skills
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning.
Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces an actionable remediation checklist tailored to the selected frameworks.
Conduct enterprise-grade financial research with multi-source synthesis, regulatory compliance tracking, and verified market analysis. Use when user needs comprehensive financial analysis requiring 10+ sources, verified claims, market comparisons, or investment research. Triggers include "financial research", "market analysis", "investment analysis", "due diligence", "financial deep dive", "compare stocks/funds", or "analyze [company/sector]". Do NOT use for simple stock quotes, basic company lookups, or questions answerable with 1-2 searches.
When the user wants to optimize pharmacy supply chain operations, manage medication distribution, ensure pharmaceutical compliance, or handle controlled substances. Also use when the user mentions "pharmacy logistics," "drug distribution," "controlled substances," "340B program," "formulary management," "medication safety," "specialty pharmacy," "drug shortages," "DEA compliance," "pharmaceutical traceability," or "DSCSA compliance." For hospital materials management, see hospital-logistics. For clinical trial drugs, see clinical-trial-logistics.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
Draft privacy policies, terms of service, disclaimers, and legal notices. Creates GDPR-compliant texts, cookie policies, and data processing agreements. Use PROACTIVELY for legal documentation, compliance texts, or regulatory requirements.
Expert-level banking systems, core banking, regulations, and banking technology
Open gaps tracker — what's flagged and not yet closed. Use when the user asks "what gaps are open", "gap tracker", "remediation status", or wants to close (--close GAP-ID) or risk-accept (--accept GAP-ID) a tracked gap.
Deeper risk assessment for a single feature or product area when the launch review found something that needs more than a line item. Structured analysis: what could go wrong, how likely, how bad, what mitigates it. Use when user says "deep dive on this risk", "risk assessment for [feature]", "what could go wrong with", or when launch-review flags a novel issue.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
Statute and regulation interpretation framework. Use when reading statutes, classifying requirements, analyzing operative keywords, applying canons of construction, or mapping compliance obligations from legislative text.