• Serves as the Research and Development Clinical Quality Assurance function in Europe. Provides sponsor quality oversight of clinical development activities for regional development programs in Europe, ensuring that investigator, supplier, and facility and system audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
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• This position provides regional leadership and strategy in line with global strategic objectives. Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements.
ACCOUNTABILITIES:
• Serves as the Clinical Quality Assurance leader in Europe in the implementation and refinement of processes to ensure that Takeda maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements.
• Collaborate with the Senior Director, Clinical Quality Assurance, Americas and Europe to develop and implement the strategy for sponsor quality oversight of regional development activities.
• Develop regional Quality Management plans for development programs, and tactical audit plans.
• Analyze audit program results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance.
• Identify compliance issues and conduct investigations for regional development activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.
• Manage inspection readiness activities and represent Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that clinical inspection commitments are fulfilled on time.
• In collaboration with R&D Clinical Supplier Quality, determine acceptability of clinical suppliers for potential use by Takeda.
• Serve as a member of the Clinical Quality Assurance Leadership team, giving input to key strategic decisions.
• Ensure strong alignment with R&D Quality Systems and Compliance and R&D Quality Services and Improvement.
• As assigned, conduct due diligence assessments of prospective in-licensing opportunities and acquisitions to identify key quality assurance and compliance risks. Conduct document reviews and on-site assessments as required.
• Ensure reports and corrective actions are developed and completed within timelines mandated in Takeda procedures.
Qualifications
EDUCATION, COMPETENCIES AND SKILLS:
• B.Sc. in Science, Nursing, or related scientific field. M.Sc. preferred.
• Extensive applicable pharmaceutical and/or biotech development experience with a solid understanding of GCP-related Quality Assurance.
• GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines.
• Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
• Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
• Product Knowledge: Understands the medical/therapeutic impact of products.
• Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
• Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.
• Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
• Organizational skills: Must be able to prioritize work effectively to meet timelines.
• Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
LICENSES/CERTIFICATIONS:
• ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
TRAVEL REQUIREMENTS:
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
• Requires approximately 50 % travel.
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