Job Title: Head, R&D Quality
Job Location: King of Prussia
Number of Positions/Incumbents: 1
Job Family Group: Quality
Job Family: Quality > Quality Multi Discipline
Business/Functional Unit: CSL Behring/R&D Quality
FLSA Status (US only): Exempt
Date: 06/2024
Level: 11
Job Purpose
The purpose of the position of Executive Director R&D Quality is to lead a dedicated team responsible for quality oversight for the entire R&D organisation through use of the quality management system and associated processes. This role is responsible for ensuring that the R&D Quality Policies and Processes are appropriate for the phase of R&D development and comply with corresponding regulations and guidance.
RESPONSIBILITIES AND ACCOUNTABILITIES To 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 and to advise on the application of these requirements, as needed. Provide direction and oversight of the execution of the 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. To lead and co-ordinate all internal and Health Authority inspections with the appropriate R&D teams. Leadership of inspection readiness plans and action plans post-inspection. 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. Chair the senior R&D Quality Management Review designed 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. To 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. To participate and contribute to key R&D Governance bodies, including the Global Safety Committee. To take an active role in educating R&D and R&D Project Management resources as to the quality requirements across the product development lifecycle. REPORTING RELATIONSHIP Reports To: Global Head of Quality
Direct Reports: ~10
JOB SPECIFICATIONS Education Requires a degree in a scientific, engineering or related discipline. Post graduate qualifications (Masters/PhD) are preferred. Experience Requires 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. Must be comfortable working in a global, matrix organization with cross-cultural experience. Experienced at communicating and influencing at senior and executive management level. Working Conditions Able to lift up to 15lbs. Travel Requirements 30% Domestic and International Travel CSL Behring LLC will provide equal employment opportunity for all persons without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status or other classification protected by applicable federal, state or local law. CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business. About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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