Job Description

Job Summary Primarily responsible for supporting the Client Research and Development quality agreement process with a focus on identifying and implementing process improvements. Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams. Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards. Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness. Achieve a difficult balance of involvement, independence, and objectivity. Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations. Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives. Consistently demonstrate Client's Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality. Roles and Responsibilities Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content. Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company. Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience Experience 5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred). 3-5 years of experience in clinical research and development or manufacturing, or analysis of investigational products. Minimum of 7 years' total combined experience required (Not necessarily the sum of the above). #J-18808-Ljbffr Katalyst CRO

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