Software Quality Assurance Engineer

Lead and Manage the System Validation Function

Lead and manages the system validation function to ensure compliance with applicable regulations and serves as a system validation expert to support the projects.

• Review and approve all validation documentation with full responsibility.
• Review dozens of validation documents on a weekly basis.
• Review and approve all validation and testing deliverables for their accuracy and quality.
• Oversee and provide guidance on test scripts, automate test scripts, and resolve issues encountered during execution of test scripts.
• Oversee Compliance Operations audit activities so that they are fully aligned with project implementation and validation/testing activities.
• Align validation team with business and IT colleagues to create positive synergy between groups and improve quality.
• Help define the validation priorities for IT.
• Investigate and evaluate new technologies, software, and tools. Submit summaries and make recommendations to management.
• Write and execute IQ/OQ/PQ /UAT /VP and VSR.

Strategic focused and business oriented technical professional with 10+ years of progressive experience in Information Technology.

• Data Warehousing and Business
• Systems/Solutions Architecture through Deployment
• All facets of SDL
• Project Management Methodologies & Frameworks
• SOA and EAI (Hub/Spoke and ESB)
• Biotech/Life, Sciences/Pharmaceutical, R&D Domains
• Solutions
• GCP, GxP and CFR 21 Part 11
• Data Management

Software Quality Assurance Lead/Manager responsible for all aspects of software compliance and for managing a team of software engineers as part of the roll‑out (Agile development methodology) of the new Software & Services Provisioning System—a SaaS cloud‑based system.

Provided guidance in drafting and approving: system Intended Use & Base Risk Statements (application & interfacing database), Legacy System Remediation Software / System Assessments (all countries), Legacy System Remediation Electronic Records/Electronic Signatures Assessment, User Requirements Specification, Validation Plan, Functional Requirements Specification, Test Plan, Hazard Risk Analysis, Requirements Traceability Analysis, Installation Verification Test Protocol, Operational Test Protocol, and Final Validation Report. At least five years of experience as SQA.

Knowledgeable with agile and waterfall development methods.

We are looking for an Enterprise Agile Coach with at least 5 years of experience.

9201 Corporate Blvd, Rockville, MD 20850