Regulated life-sciences cloud environment
Policy-as-Code and Compliance Engineering for Regulated AWS Workloads
Overview
Engineered policy-as-code controls for regulated AWS workloads, translating security findings and GxP classification into testable profiles, evidence, exception handling, and controlled rollout.
Context / Problem
A regulated AWS estate needed cloud controls that reflected workload classification instead of treating every environment identically. Security findings, infrastructure definitions, qualification evidence, exceptions, and team practices had to align in a repeatable control lifecycle.
My Role
I analyzed cloud security findings, shaped differentiated control profiles, implemented policy-as-code checks, connected them to infrastructure validation, and produced the evidence, exception, rollout, and enablement material around the controls.
What I Did
- Translated requirements and classification into common, GxP, and risk-appropriate non-GxP control expectations.
- Implemented and tested OPAL and LQL policy logic against Terraform and CloudFormation patterns.
- Documented evidence, exceptions, rollout decisions, and GxP and security enablement for delivery teams.
Architecture
Requirements and workload classification select the appropriate control profile. Policy-as-code evaluates infrastructure definitions in the delivery flow, findings become reviewable evidence, and exceptions follow a documented path before controlled rollout and team enablement.
- RequirementsImplemented
- Workload classificationImplemented
- Control profilesImplemented
- Policy as codeImplemented
- IaC / CI validationImplemented
- Findings and evidenceImplemented
- Exceptions and rolloutImplemented
- EnablementImplemented
Classification determines the applicable profile; evidence and exceptions remain reviewable.
Key Decisions / Trade-offs
- Differentiate controls by classification
- A stricter GxP profile and a risk-appropriate non-GxP baseline aligned effort with regulated impact while retaining common controls.
- Treat evidence and exceptions as first-class outputs
- A policy result is operationally useful only when teams can understand its evidence, ownership, and governed exception path.
Implementation Scope
Policy definitions, infrastructure validation, evidence handling, exception support, rollout material, and enablement were implemented for the applicable AWS control context. The work covered controls and their delivery lifecycle rather than an external certification claim.
Safety / Security / Governance
The design linked CSPM findings, workload classification, policy checks, test evidence, documented exceptions, and controlled introduction. Public copy avoids organization names, internal rule identifiers, exact estate coverage, and unsupported compliance outcomes.
Scope Boundary
This case covers implemented policy and control engineering in a regulated environment. It does not claim certification, universal control coverage, a quantified compliance outcome, or ownership of every remediation. Organizational identities and private control identifiers remain excluded.