QA Associate Systems & Tools Management

Job Title: Quality Assurance (QA) Team Lead QA Systems & Tools Management (QMS).

Role detailed classification

QA Team Lead - Systems & Tools Management (QMS)

Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Quality Assurance (QA) Team Lead (TL) Systems & Tools Management (QMS) to join our LS Practice team. The QA Team Lead oversees quality systems documentation control and QMS operations to ensure compliance with regulatory standards (GMP ISO ICH). This leadership role drives continuous improvement audit readiness and cross-functional collaboration across manufacturing regulatory and quality teams. The QA TL supports the development implementation and maintenance of Quality Management Systems (QMS) ensuring that documentation and processes comply with regulatory standards such as GMP ISO and ICH guidelines. This role is pivotal in managing and maintaining audit readiness and driving continuous improvement across quality systems. The role will involve knowledge of cGMP GLP and Global Regulatory Affairs guidelines platforms and systems to undertake various assigned roles and responsibilities included but not limited to below-described activities.

Key Responsibilities:

Life Sciences QA Team Lead QMS plays a crucial role in ensuring compliance within the pharmaceutical medical devices and biotechnology industries by managing the team for the assigned QA activities for ensuring compliance & ATR All Time Readiness for Regulatory and System Internal audits. This role involves overseeing & quality check for preparation enteries and reviewing Quality information maintaining compliance with global standards and regulations and utilizing QA systems to track and organize critical data for various assigned activities.

Specific QA Team Lead activities

Team Leadership & Collaboration

• Mentor and manage QA associates and review & ensure quality of QMS & other activities undertaken by the team.
• Act as QA representative in cross-functional meetings and client programs
• Support internal and external audits including regulatory inspections
• Drive continuous improvement initiatives and root cause analysis

Managing Productivity & Quality from QA team associate activities and undertake as necessary:

1. Manage and maintain QMS components including:

• Document control systems (SOPs policies work instructions)
• Change control deviation CAPA and training records
• Audit trail and compliance tracking

2. Coordinate creation review approval and archival of quality documentation

3. Ensure version control and accessibility of documents in electronic systems (e.g. Veeva MasterControl)

4. Support internal and external audits by preparing documentation and tracking findings

5. Collaborate with cross-functional teams to ensure timely updates and implementation of quality procedures

6. Monitor QMS performance metrics and generate reports for management

7. Identify gaps in documentation and recommend improvements

8. Train staff on QMS procedures and documentation best practices

9. Quality Management System (QMS): Utilizing the assigned system(s) to manage and maintain information track submissions health authority correspondence and approvals across regions and functions. Support data migration configuration validation and user acceptance testing (UAT).

10. Maintain and update Quality data in QA systems (e.g. Veeva QMS MasterControl Track-wise etc.) to ensure accuracy completeness and compliance

11. Support QA documentation by coordinating data entry document tracking and metadata management

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

13. Generate reports and dashboards for compliance tracking and data quality metrics

14. Assist in audits and inspections by ensuring traceability and readiness of Quality records

15. Participate in system upgrades and validation activities including testing and documentation

General responsibilities

1. Compliance and Standards: Ensuring adherence to global regulatory guidelines such as ICH ICH-GCP GMP and managing QMS and maintenance across products/ sites.

2. Cross-functional Collaboration: Working with various client teams (e.g. RA Manufacturing etc.) to ensure timely and accurate information and ongoing compliance. Monitor changes and ensure QA system compliance. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history

Qualifications & experience:

• Preferably Postgraduate/ PhD. degree in Pharmacy/ Life Sciences or a related field.
• 6-8 years in LS QA document control within GMP-regulated environments and including at least about 2 years experience in leading RA authoring team(s).
• Knowledge of and Proficiency in QMS platforms ( (e.g. Veeva QMS MasterControl Track-wise etc.) and electronic document management systems (EDMS) is mandatory.
• Good to have knowledge of eCTD Lorenz GlobalSubmit etc. Proven experience in requirement gathering documentation and stakeholder management Familiarity with eCTD IDMP XEVMPD and GxP compliance Experience with CSV/validation support is a plus.
• Basic knowledge of industry standards and regulations related to Quality Management Systems (e.g. ISO 9001 ISO 13485 FDA & Global Health authority regulations).
• Excellent communication collaboration presentation and stakeholder management skills.
• Strong analytical attention to detail and problem-solving abilities.
• Stable track record in LS Quality Assurance domain in a Mid-large Organisation.
• Proficiency in MS Office Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA MHRA EMA APAC GCC LatAm for Medical Devices and/or Medicinal/ Biotech products.