Position Title

Head - Quality Assurance (QA)

Department

Quality Assurance

Reporting To

Test Facility Management

Location

Bangalore

Employment Type

Full-time

Key Responsibilities

Quality Assurance Programme Management

- Lead and manage the GLP Quality Assurance Unit (QAU).
- Develop, implement, and maintain an effective quality management system aligned with OECD GLP principles and ISO 17025.
- Ensure independence of the Quality Assurance Unit from study conduct activities.
- Establish annual QA plans, inspection schedules, and risk-based audit programmes.
- Monitor compliance with regulatory requirements and industry best practices.

GLP Compliance Oversight

- Verify that studies are planned, performed, monitored, recorded, reported, and archived in accordance with approved protocols, SOPs, and GLP requirements.
- Ensure compliance with OECD GLP Principles and applicable national regulatory requirements.
- Conduct periodic reviews of quality systems to identify potential compliance gaps.
- Maintain readiness for regulatory inspections and external audits.

Inspections and Audits

- Plan, conduct, supervise, and review:
- Facility inspections
- Process inspections
- Study-based inspections
- Data audits
- Raw data reviews
- Archival inspections
- Supplier and subcontractor audits

- Prepare inspection reports and communicate findings to Test Facility Management and Study Directors.
- Verify implementation and effectiveness of corrective and preventive actions (CAPA).

Study Monitoring

- Review study protocols, protocol amendments, and final reports from a QA perspective.
- Monitor critical phases of ongoing studies.
- Verify accurate recording of raw data and traceability of study activities.
- Provide QA statements for final study reports in accordance with GLP requirements.

Documentation and SOP Management

- Oversee creation, review, approval, implementation, and periodic revision of Standard Operating Procedures (SOPs).




- Ensure document control systems are maintained and effective.
- Monitor deviations, incidents, change controls, and quality events.
- Ensure proper document retention and version control.

CAPA and Risk Management

- Lead investigations into deviations, non-conformances, and quality incidents.
- Facilitate root cause analysis and implementation of CAPA.
- Track CAPA effectiveness and closure.
- Promote a proactive risk-based quality culture throughout the organization.

Training and Competency Development

- Ensure GLP training programmes are developed and implemented.
- Assess competency of QA personnel and laboratory staff.
- Conduct GLP awareness sessions and internal quality training programmes.
- Maintain training records and qualification matrices.

Computerized Systems and Data Integrity

- Oversee quality compliance of computerized systems utilized in GLP studies.
- Ensure compliance with data integrity principles including ALCOA+ requirements.
- Participate in validation, qualification, and change control review activities.
- Audit electronic data management systems and electronic records.

Regulatory Inspection Management

- Coordinate preparations for GLP authority inspections, client audits, and regulatory audits.
- Act as primary QA representative during inspections.
- Lead responses to observations and regulatory findings.
- Track closure of regulatory commitments.

Vendor and Service Provider Qualification

- Review and assess quality systems of vendors, subcontractors, and service providers.
- Participate in qualification and periodic evaluation activities.




- Ensure quality agreements are established and maintained where applicable.

Leadership and Team Management

- Lead, mentor, and develop the Quality Assurance team.
- Establish departmental objectives and KPIs.
- Foster a culture of quality, compliance, and continuous improvement.
- Support strategic quality initiatives across the organization.

Qualifications

Education

- Master's degree in Life Sciences, Toxicology, Biotechnology, Pharmacy, Veterinary Sciences, Chemistry, Biological Sciences, or related discipline.
- PhD preferred.

Experience

- Minimum 10-15 years of experience in regulated laboratory environments.
- Minimum 5 years in GLP Quality Assurance leadership roles.
- Extensive experience in OECD GLP-compliant testing facilities.
- Experience handling regulatory inspections and audits.
- Experience in toxicology, ecotoxicology, analytical, pharmaceutical, agrochemical, environmental, or related testing environments preferred.

Technical Knowledge

Strong knowledge of

- OECD Principles of Valuable Laboratory Practice
- National GLP Compliance Monitoring Programme requirements
- Quality Management Systems
- Laboratory audits and inspections
- Data Integrity (ALCOA+)
- CAPA methodologies
- Risk management tools
- Computerized System Validation (CSV)
- Document control systems
- Regulatory inspection management
- Archival requirements and records management

Key Competencies

Leadership Competencies

- Strategic thinking
- Team leadership and development
- Decision-making
- Stakeholder management
- Change management

Functional Competencies

- Audit and inspection expertise
- Root cause analysis
- Quality systems management
- Regulatory compliance
- Risk assessment
- Problem-solving

Behavioral Competencies

- High ethical standards
- Attention to detail
- Integrity and objectivity
- Excellent communication skills
- Influencing and collaboration skills

📌 Head - QA (Bengaluru)
🏢 Tuv Sud South Asia PrivateLimited
📍 Bengaluru