QA Team Lead

QA Team Lead 843

Job Summary

Life Sciences Quality Assurance (QA) Team Lead – Systems & Tools Management (QMS)

GMP, ISO, ICH, cGMP, and GLP

Key Responsibilities

Team Leadership & Collaboration

• Lead, mentor, and manage QA associates; ensure quality and accuracy of QMS-related activities.
• Act as a QA representative in cross-functional meetings and client programs.
• Support internal and external audits, including regulatory inspections.
• Drive continuous improvement initiatives, RCA activities, and best-practice implementation.
  

QMS Operations & Documentation Control

• Manage and maintain QMS components including:
• Document control systems (SOPs, policies, work instructions)
• Change control, deviations, CAPA, and training records
• Audit trail and compliance monitoring
• Coordinate creation, review, approval, and archival of QA documentation.
• Ensure document version control and accessibility in electronic systems (e.g., Veeva QMS, MasterControl).
• Prepare documentation and track findings for internal/external audits.
• Work with cross-functional teams to implement timely updates to quality procedures.
• Monitor QMS performance metrics and prepare management reports.
• Identify documentation gaps and recommend improvements.
• Train associates on QMS processes, documentation standards, and compliance expectations.
  

Systems & Tools Management

• Utilize assigned QMS systems to manage and track information, submissions, correspondence, and approvals.
• Maintain and update Quality data in systems such as Veeva QMS, MasterControl, TrackWise, ensuring compliance and data completeness.
• Support QA documentation activities including data entry, tracking, and metadata management.
• Collaborate with cross-functional teams (Regulatory Affairs, CMC, Clinical, Safety) to gather and validate quality-related information.
• Generate compliance, tracking, and data quality dashboards and reports.
• Assist in audits and inspections by ensuring traceability and readiness of QA records.
• Participate in system upgrades, enhancements, validation, and UAT documentation.
  

General Responsibilities

• Ensure adherence to global regulatory guidelines (ICH, ICH-GCP, GMP) and manage QMS operations across products/sites.
• Collaborate with RA, Manufacturing, and other teams to ensure timely, accurate information exchange.
• Support audits by regulatory bodies and notified agencies through effective record management and readiness.
  

Qualifications & Experience

• Postgraduate/PhD in Pharmacy, Life Sciences, or related fields (preferred).
• 6–8 years of experience in Life Sciences QA within GMP-regulated environments.
• Minimum 2 years of experience leading QA/RA authoring teams.
• Proficiency with QMS platforms like Veeva QMS, MasterControl, TrackWise (mandatory).
• Good to have: Knowledge of eCTD, Lorenz, GlobalSubmit, IDMP, XEVMPD, CSV/validation.
• Strong knowledge of ISO standards (ISO 9001/13485), FDA, and global health authority regulations.
• Excellent communication, presentation, and stakeholder management skills.
• Strong analytical and problem-solving abilities.
• Proven job stability in mid-to-large Life Sciences organizations.
• Proficiency in MS Office and good understanding of global regulatory submission requirements (USFDA, MHRA, EMA, APAC, GCC, LatAm).
  

Skills (Must-Haves)

• Systems & Tools Management
• Document Control Systems
• Version Control
• Quality Management Systems (QMS)