Manager, Clinical Quality Assurance
Asahi Kasei

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 GCP activities related to clinical trials sponsored by the Company.

Summary of Key Responsibilities

• Manages global studies for one or more product candidates from early development to regulatory approval (Phases 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for the Company in cooperation with clinical development departments;
• Represents quality assurance on key sponsor and study project team including dissemination of key Quality information, guidance, training, and support;
• Participates in the evaluation and qualification of CROs and other clinical vendors/suppliers in coordination with Clinical Operations teams;
• Ensures clinical processes are conducted in accordance with the Company's procedures and applicable regulatory GCP requirements, sponsor SOPs, study protocols, and current industry standards, regulations, and guidelines;
• Captures QA metrics and surveillance risk assessment for clinical programs. Drives inspection readiness by organizing and overseeing mock GCP inspections. Represents Veloxis in regulatory authorities GCP inspections;
• Confirms company Clinical SOPs are clear, consistent and aligned with other related SOPs;
• Conducts Investigator Site, Trial Master File (TMF), Vendor, System/Process Audits, investigator brochure and clinical Protocol/Study Plan reviews/audits in cooperation with Clinical Operations;
• Reviews clinical and regulatory documents, ensuring quality, accuracy, and completeness;
• Authors audit plans, executes audits and publishes audit reports ensuring that audit findings/observations are addressed and resolved in a timely manner;
• Collaborates with auditees and audit stakeholders to ensure appropriate root cause identification understanding and alignment. Tracks, reviews, approves, and assesses the adequacy of CAPAs through completion;
• Works closely with development team to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, temperature excursions, product complaints, deviations etc., in a timely manner;
• Identifies and remediates potential systemic gaps and coordinates with the appropriate stakeholders;
• Escalates issues of critical non-compliance and/or lack of urgency in remediation to Quality Assurance and Clinical Operations teams;
• Performs other duties as assigned by manager.

Required Qualifications and Skills

• BS, preferably in a scientific/technical discipline.
• Experience working at a CRO
• Minimum of 5 years of Clinical Quality Assurance experience required, with 3 years of auditing experience/oversight 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, collaborates with other team members in a positive manner, and works in a leadership role.
• Excellent organizational skills and ability to work on multiple projects with competitive timelines are required.
• 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 cross functional team environment.
• Strong proficiency with Microsoft Office Suite and clinical trial software/programs
• Ability to travel occasionally, 25% of the time or less.

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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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