Senior Director of Quality Assurance and Operations

2 weeks ago

Hyderabad, Telangana, India Tentamus Full time

Estimate Salary: $120,000 - $180,000 per year

About Tentamus

Tentamus is a leading US-FDA approved business that provides analytical testing services to pharmaceutical and related companies. The services comprise elemental impurity studies, E&L studies, method development & validation, and microbiological testing.

About the Role

The Senior Director of Quality Assurance and Operations will play a key role in ensuring the smooth functioning of testing activities in multiple food matrices, gaining customer trust through timely deliverables, and maintaining sustainable compliance.

Key Responsibilities
  • Operational Excellence:
    • Evaluate client queries on method feasibilities, requisites, and communicate the key assumptions of scope work.
    • Draft project agreements, scope of work with required details, and ensure thorough evaluation.
    • Ensure all pre-requisites, including samples, standards, facilities, instrument, reagents, and resources are available prior to work initiation.
    • Review contracts, facilitate prerequisite availability, and allocate resources on time.
    • Approve analyst qualification, ensure quality documents, and guide teams in conflict resolution.
    • Review project progress, resource allocation, and monitor instrument performance.
    • Develop process improvement plans, identify facility upgrades, and drive business focus areas.
  • Human Resource Management:
    • Coordinate between teams, resolve conflicts, and select/hire associates as needed.
    • Facilitate approvals, manage workload, and conduct performance management.
  • Client Management:
    • Support teams in understanding scope work before acceptance.
    • Participate in client calls, finalize projects, and coordinate with BD teams.
    • Review contracts, communicate with clients, and execute projects according to agreed timelines.
  • Quality Management:
    • Perform activities according to written procedures and establish necessary controls.
    • Review existing procedures, suggest quality improvements, and supervise system adherence.
    • Participate in audits, implement CAPAs, and strive for regulatory compliance.
  • Business Objectives:
    • Align daily operations with committed timelines.
    • Measure activities by cost and/or time, devise improvement plans, and identify new capabilities.
    • Report internal and external customer opinions, estimate requirements, and make business plans.
  • Safety, Health, and Environment:
    • Ensure employees work in a safe environment.
    • Foster safety practices, provide necessary PPE, and devise safe handling/disposal practices.
    Secondary Responsibilities
    • Get test methods validated, maintain master calibration records, and verify critical calibrations.
    • Develop and validate new cost-effective methods, provide cross-functional training, and motivate team members.
    Requirements and Skillset
    • Leadership skills with goal setting and prioritization.
    • Analytical mindset, excellent communication, writing, leadership, interpersonal, and customer service skills.
    • Data-driven thinking, knowledge of regulatory/certification body requirements.

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