Sr. Director / Director Quality Systems and Compliance
Veloxis Pharmaceuticals, Inc.

Job Info

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The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:
Veloxis Pharmaceuticals, Inc.

Job Description:

This position contributes to the Company's success by managing the development, maintenance, and oversight of the Company's Quality Systems and Regulatory Compliance.

Summary of Key Responsibilities

• Develops and implements a quality management system that aligns with the Company's vision, mission, values, and goals, ensuring compliance with relevant standards and regulations.
• Maintains all controlled documents (electronic and hard copies) in accordance with the Company's internal SOPs, quality agreements, and licensing partner expectations.
• Supports eQMS implementation.
• Supports Quality management review by consolidating metrics from key stakeholders and tracking activities/actions.
• Owns and develops KPIs for document control, periodic review, and employee training.
• Leads and facilitates cross-functional teams and projects that support the Company's strategic objectives and priorities and fosters collaboration and knowledge sharing across the organization.
• Develops and implements GMP training tools including training curriculum/matrix and relevant eQMS modules.
• Researches and benchmarks best practices and emerging trends in the training and quality fields, incorporating them into the training and quality strategy and plans.
• Designs and delivers innovative and effective learning and development programs aligned with the Company's strategic goals and quality standards.
• Understands and assesses opportunities and innovations delivered by LMS and platform providers and emerging technologies from third-party vendors. Actively explores platforms and tools to validate their value based on the Company's learner solution needs.
• Works with stakeholders in analyzing and interpreting learning technology needs to understand current capabilities; advises on the best use of the Company's current and potential offerings and helps drive and develop a digital mindset.
• Continually improves the customer experience, and implements long-range visions for future initiatives, strategies, and objectives.
• Develops, prototypes, pilots, and embeds new technologies into the Company's internal learning ecosystem, including the production of any process documentation for its adoption.
• Prepares and submits content and site documents into the review process, tracks, and follows up to ensure content owners manage deliverables.
• Creates and manages content matrices for all groups using ACTO, Veeva, and any future online learning platforms.
• Serves as primary point of contact for the team, resolving any issues or conflicts and escalating them as needed, and maintaining strong relationships with key stakeholders across the organization.
• Monitors and evaluates the effectiveness of the QMS, implementing improvements as needed.
• Ensures compliance with all relevant regulatory requirements, including FDA, ISO, and other applicable standards.
• Oversees internal and external audits, ensuring timely resolution of findings and implementation of corrective actions.
• Conducts regular risk assessments and implements preventive measures to ensure product and process quality.
• Collaborates with cross functional teams to address and resolve quality issues promptly.

Required Qualifications and Skills

• Minimum of 10 years' experience required, with 5 years' experience in the regulatory compliance environment or an equivalent combination of education and experience.
• Excellent communication and negotiation skills, capable of making decisions, problem-solving, collaborating with other team members in a positive manner, working effectively as a leadership.
• Excellent organizational skills, with the ability to work on multiple projects with competitive times.
• Strong attention to detail.
• Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials.
• Demonstrated ability to work effectively in a cross-functional team environment.
• Strong proficiency in MS Office Suite and clinical trial software/programs.

Travel Requirements: Approximately 25%

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As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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