QA Testing Lead - GxP/GMP

About Aligned Automation

At Aligned Automation, we live by our "Better Together" philosophy to build a better world. As a strategic service provider to Fortune 500 companies, we help digitize enterprise operations and drive impactful business strategies. Our purpose goes beyond projects—we strive to deliver meaningful, sustainable change that shapes a more optimistic and equitable future.

Our culture is deeply rooted in our 4Cs—Care, Courage, Curiosity, and Collaboration—ensuring that each employee is empowered to grow, innovate, and thrive in an inclusive workplace.

We are seeking an experienced QA Lead to oversee the testing and validation of GxP/GMP-regulated computerized systems within the pharmaceutical, biotech, or life sciences domain. The ideal candidate will have a deep understanding of Computer System Validation (CSV) principles, 21 CFR Part 11, GAMP 5, and Annex 11 regulatory frameworks.

This role involves defining the testing strategy, managing QA teams, and ensuring all systems and applications meet compliance, quality, and business requirements through structured validation and documentation processes.

Key Responsibilities

• Lead, mentor, and guide a team of QA testers to ensure timely and high-quality delivery of validation and testing activities.
  
• Define and implement QA strategies, validation frameworks, and best practices for regulated systems.
  
• Develop, review, and approve test plans, protocols (IQ, OQ, PQ), test scripts, and validation deliverables (RTM, TCR, TSR).
  
• Ensure all QA activities comply with GxP, GMP, CSV, and data integrity requirements.
  
• Collaborate with Business Analysts, Developers, and Validation teams to ensure traceability from requirements to testing.
  
• Drive defect management and ensure timely resolution of issues with development teams.
  
• Participate in audits and regulatory inspections, providing evidence of validation and QA compliance.
  
• Establish and monitor KPIs and quality metrics for testing performance and compliance adherence.
  
• Identify opportunities to automate testing and streamline validation processes.
  
• Ensure adherence to SOPs, change control, and quality standards throughout the SDLC.
  
• Provide leadership in continuous improvement initiatives to enhance QA processes and documentation quality.
  

Required Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
  
• 8+ years of experience in QA/Testing roles, with at least 3+ years in a QA Lead or Senior QA position.
  
• Strong knowledge of GxP, GMP, CSV, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
  
• Proven experience managing validation and testing for pharmaceutical or biotech systems (LIMS, MES, ERP, Tulip, Power Apps, etc.).
  
• Expertise in preparing and reviewing validation documentation as per regulatory expectations.
  
• Proficiency in test management and defect tracking tools (HP ALM/QC, Jira, TestRail).
  
• Excellent understanding of SDLC, Agile, Waterfall, and V-model methodologies.
  
• Strong analytical, problem-solving, and communication skills with the ability to collaborate across functions.
  

Preferred Skills

• Experience with automation testing tools (e.g., Selenium, TestComplete, Tricentis Tosca).
  
• Exposure to cloud-based and low-code/no-code platforms (e.g., Tulip, Power Apps, Salesforce).
  
• Knowledge of Lean, Six Sigma, or process improvement methodologies.
  
• Prior experience supporting regulatory audits or client inspections.
  

Key Attributes

• Strong leadership and mentorship capabilities.
  
• Detail-oriented with a focus on compliance and documentation integrity.
  
• Ability to manage multiple projects in a regulated environment.
  
• Excellent communication, planning, and stakeholder management skills.