What are the responsibilities and job description for the Director, Quality systems position at Skills Alliance?
The company is a cutting-edge clinical-stage biotechnology company mainly dedicated to the Nephrology space. They have a dynamic pipeline of groundbreaking therapies.
As the Director, Quality & Compliance, you will take a leading role in advancing and overseeing the Quality Management System to align with relevant global regulatory standards and company business goals. This position offers significant visibility within the organization.
Responsibilities
- Oversee companywide GxP training programs, aligning training requirements with job functions.
- Lead the development and maintenance of the audit and inspection readiness programs.
- Contribute to the continuous improvement of the inspection readiness program and new initiatives.
- Develop, review, and monitor quality agreements and contracts.
- Manage GxP Training, Supplier Management, and documentation systems.
- Support the Quality Management Review process by analyzing and reporting on Quality System and supplier performance metrics.
- Oversee the supplier qualification program, including audit planning and execution.
- Develop and enhance scalable quality processes to meet organizational growth.
- Cultivate a quality mindset across the company through risk-based decision-making.
- Assist in presenting management reviews of quality compliance and operational KPIs to address unfavorable trends promptly.
- Minimum 15 years in Biopharmaceutical Quality or Compliance roles
- BA / BS Degree in a sciences discipline
- In-depth knowledge of GxP, Quality Systems, and Compliance for safety, data integrity, and product quality
- Recent experience managing and influencing stakeholders on GxP topics
- Experience in leading inspection readiness initiatives
- Experience with Veeva and ComplianceWire
Qualifications
Please reach out to David.fearnley@skillsalliance.com or call 1 646 492-5308 for further details.
Salary : $230,000
