Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Ensure that processes needed for the Houston quality management system are established and documented.
- Monitor and report on the effectiveness of the quality management system and needed improvements.
- Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Liaise with and influence central groups on corporate quality standards and initiatives.
- Sponsors site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation; acts as connection for global initiatives related to quality and compliance for local implementation.
- Ensure creation and manage Site Quality Plan and Site Quality Manual and ensure adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems, etc.).
- Provide direction for the site-wide quality governance boards (e.g., site quality lead team, deviation review board, change control review board, etc.)
- Ensure adequate quality oversight for material and supplier management, incoming controls, complaints, etc.
- Lead and model behaviors foundational to strong quality culture.
- Coordinate and manage regulatory inspections and lead the site inspection readiness program.
- Acts as liaison with Regulatory for Site Licenses and declarations, Site Master file, and other Regulatory Compliance related documents.
Qualifications
Highest qualification: University
- Demonstrated capability to effectively prioritize tasks and responsibilities
- Ability to work independently
- Excellent communication skills, both written and verbal, allowing for clear and concise expression of ideas, instructions, and feedback.
- Effective decision-making
- Exceptional ability to build and maintain positive relationships with colleagues, clients, and stakeholders
- Fundamental knowledge of computer applications
- Strong problem-solving skills
- Experienced in creating clear and comprehensive procedures and training materials
- Proven ability to mentor and lead others, providing guidance, support, and motivation to help them achieve their goals.