QA Team Lead

QA Team Lead 843

We are seeking a highly skilled and experienced Life Sciences Quality Assurance (QA) Team Lead – Systems & Tools Management (QMS) to join our Life Sciences Practice.
This role involves leading QA teams, managing Quality Management Systems (QMS), and ensuring compliance with global regulatory standards such as GMP, ISO, ICH, cGMP, and GLP.

The QA Team Lead will oversee QMS components, documentation control processes, audit readiness, and continuous improvement initiatives. The position requires strong expertise in QA systems, regulatory guidelines, and cross-functional collaboration across manufacturing, regulatory, and quality functions.

• 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.

1. 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

2. Coordinate creation, review, approval, and archival of QA documentation.

3. Ensure document version control and accessibility in electronic systems (e.g., Veeva QMS, MasterControl).

4. Prepare documentation and track findings for internal/external audits.

5. Work with cross-functional teams to implement timely updates to quality procedures.

6. Monitor QMS performance metrics and prepare management reports.

7. Identify documentation gaps and recommend improvements.

8. Train associates on QMS processes, documentation standards, and compliance expectations.

1. Utilize assigned QMS systems to manage and track information, submissions, correspondence, and approvals.

2. Maintain and update Quality data in systems such as Veeva QMS, MasterControl, TrackWise, ensuring compliance and data completeness.

3. Support QA documentation activities including data entry, tracking, and metadata management.

4. Collaborate with cross-functional teams (Regulatory Affairs, CMC, Clinical, Safety) to gather and validate quality-related information.

5. Generate compliance, tracking, and data quality dashboards and reports.

6. Assist in audits and inspections by ensuring traceability and readiness of QA records.

7. Participate in system upgrades, enhancements, validation, and UAT documentation.

• 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.

• 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).

• Systems & Tools Management

• Document Control Systems

• Version Control

• Quality Management Systems (QMS)