Job Title: Test Facility Manager (TFM)

Location: Bangalore

Reporting To: Head of MHS

Employment Type: Full-Time

Key Responsibilities

GLP Compliance & Regulatory Oversight

- Ensure the testing facility operates in full compliance with OECD GLP Principles and applicable national regulatory requirements.
- Establish, implement, and maintain organizational structures, procedures, and resources necessary to conduct GLP studies.
- Ensure that approved Standard Operating Procedures (SOPs) are available, implemented, and periodically reviewed.
- Oversee readiness for regulatory inspections, facility audits, and GLP monitoring authority assessments.
- Ensure corrective and preventive actions (CAPA) are effectively implemented and monitored.

Facility Management

- Manage day-to-day operations of the testing facility, including laboratories, animal facilities (if applicable), archives, stores, and support services.
- Ensure adequate infrastructure, utilities, environmental controls, and maintenance programs are in place.
- Oversee calibration, qualification, validation, and maintenance of laboratory equipment and computerized systems.
- Ensure adequate staffing and competency levels across all facility functions.

Study Management Support

- Ensure qualified personnel are available for conduct of studies.
- Verify that Study Directors have the necessary resources to perform studies in compliance with GLP requirements.
- Facilitate communication among Study Directors, Principal Investigators, QA personnel, and laboratory staff.
- Monitor laboratory capacity, resource planning, and study scheduling.

Quality Assurance & Risk Management

- Support and promote a robust quality culture throughout the organization.
- Ensure an independent Quality Assurance Unit (QAU) is established and adequately resourced.
- Review quality trends, audit findings, deviations, and CAPA effectiveness.
- Lead risk assessments and continuous improvement initiatives.

Personnel Leadership & Development

- Recruit, train, mentor, and evaluate scientific, technical, and operational staff.
- Ensure all personnel are adequately trained and training records are maintained.
- Foster a collaborative, protected, and high-performance work environment.




- Establish succession planning and competency development programs.

Resource & Budget Management

- Prepare and manage departmental budgets and capital expenditure plans.
- Monitor utilization of laboratory resources and optimize operational efficiency.
- Manage procurement of equipment, consumables, and contracted services.
- Support business growth through facility expansion and capability enhancement initiatives.

Documentation & Records Management

- Ensure proper maintenance, retention, and archiving of GLP records and study data.
- Ensure integrity, confidentiality, and traceability of data and documentation.
- Oversee implementation of data integrity and computerized system compliance requirements.

Health, Safety & Environment

- Ensure compliance with laboratory safety, biosafety, environmental, and occupational health regulations.
- Promote safe working practices and investigate incidents, deviations, and near misses.
- Ensure emergency preparedness and response procedures are established and maintained.

Qualifications

Education

- Master's degree or Ph.D. in Life Sciences, Toxicology, Pharmacy, Veterinary Sciences, Chemistry, Biotechnology, Microbiology, Environmental Sciences, or related discipline.
- Additional certification in Quality Management, GLP, Regulatory Affairs, or Laboratory Management is desirable.

Experience

- Minimum 12 – 20 years of experience in a GLP-compliant testing, research, contract research, toxicology, Biocompatibility, pharmaceutical, agrochemical, or related laboratory.
- Minimum 5 years in a leadership or facility management role.
- Demonstrated experience with GLP inspections, audits, and regulatory interactions.
- Experience managing multidisciplinary scientific and technical teams.

Technical Competencies

- Comprehensive knowledge of OECD GLP Principles and ISO 17025.
- Understanding of toxicology, analytical chemistry, Biocompatibility, microbiology,



or related testing disciplines.
- Knowledge of quality management systems and regulatory compliance requirements.
- Familiarity with computerized systems validation and data integrity requirements.
- Robust understanding of laboratory equipment qualification and calibration programs.
- Experience with CAPA, change control, deviation management, and risk assessment processes.

Behavioral Competencies

- Strong leadership and people management skills.
- Strategic thinking and decision-making ability.
- Excellent communication and stakeholder management skills.
- Strong problem-solving and analytical skills.
- High ethical standards and commitment to quality and compliance.
- Ability to manage multiple priorities in a regulated environment.

Key Performance Indicators (KPIs)

- Successful GLP and ISO 17025 inspection outcomes.
- Regulatory compliance status.
- Number and severity of audit observations.
- CAPA closure effectiveness and timeliness.
- Laboratory operational efficiency and resource utilization.
- Training compliance and personnel competency metrics.
- Equipment uptime and maintenance compliance.
- Customer satisfaction and project delivery timelines.

Preferred Experience

- OECD GLP Test Facility Management experience.
- Experience in Contract Research Organization (CRO) environments.
- Exposure to pharmaceutical, industrial chemical, environmental, or medical device testing.
- Experience supporting international regulatory submissions.

Authority of the Position The Test Facility Manager shall have the authority to:

- Allocate personnel and facility resources.
- Approve and implement facility-wide SOPs.
- Ensure independent functioning of the Quality Assurance Unit.
- Suspend laboratory activities that compromise GLP compliance, quality, safety, or data integrity.
- Approve training, equipment qualification, and operational systems required for GLP compliance.

What We Are Looking For

- Proven leadership and people-management skills.
- Strong compliance, quality, and operational management expertise.
- Excellent communication, planning, and problem-solving abilities.
- Commitment to scientific integrity, data quality, and regulatory excellence.

📌 Test Facility Manager (Bengaluru)
🏢 Tuv Sud South Asia PrivateLimited
📍 Bengaluru