QA LEAD - GxP/GMP

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Role Overview

QA Lead

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.