Executive Director, Quality Oversight

7 days ago


King of Prussia, Pennsylvania, United States CSL Behring Full time
Job Summary

We are seeking an experienced Executive Director to lead our Quality Oversight team at CSL Behring. As a key member of our organization, you will be responsible for ensuring the highest standards of quality in our research and development processes.

Key Responsibilities
  • Quality Systems and Standards: Establish and maintain a set of clearly documented quality systems, standards, and procedures defining the requirements for each stage of new and lifecycle development products.
  • Quality Oversight and Audits: Provide direction and oversight of the execution of the Quality Management System (QMS) specifically for Clinical and Combination Products/Medical Devices, Pharmacovigilance, and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and external vendors.
  • Inspection Readiness and Leadership: Lead and coordinate all internal and Health Authority inspections with the appropriate R&D teams. Leadership of inspection readiness plans and action plans post-inspection.
  • Quality Interfaces and Governance: Accountable for Quality interfaces end-to-end in the development process from early phase research to GMP manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs, Project Management, Operations, and Commercial Operations to ensure effective QMS transition between R&D and Commercial processes.
  • Quality Management Reviews: Chair the senior R&D Quality Management Review to ensure visibility and governance for the performance and improvement of the QMS to R&D leadership. Ensure Quality Management Reviews occur within the R&D GxP functions and issues are escalated to the senior R&D Quality Management Review.
  • Supplier Qualification and Governance: Define and manage the process for Quality supplier qualification of vendors contracted by R&D, from service providers to CROs/CMOs, inclusive of a routine quality governance as described in Quality Agreements.
  • Global Governance and Education: Participate and contribute to key R&D Governance bodies, including the Global Safety Committee. Take an active role in educating R&D and R&D Project Management resources as to the quality requirements across the product development lifecycle.
Requirements
  • Education: Requires a degree in a scientific, engineering, or related discipline. Postgraduate qualifications (Masters/PhD) are preferred.
  • Experience: Requires a minimum of 10 years of experience with equal exposure to both R&D and Quality in R&D. Quality experience should include audit participation at some level. Understanding of R&D clinical operations, clinical supply, and Pharmacovigilance is essential. Experience of GMP Quality is also valuable. Knowledge and experience of leading Health Authority inspections are required.
  • Competencies: Proven leadership, organizational, and interpersonal skills, including decision quality, innovation management, interpersonal savvy, managing vision and purpose, and customer focus.
Working Conditions
  • Able to lift up to 15lbs.
Travel Requirements
  • 30% Domestic and International Travel


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