The purpose of this position is to provide a regional resource to lead TGRD US functional teams in the identification and mitigation of systemic issues which may compromise the compliance of Takeda’s drug development operations. The person in this position will work with PDD Global Quality Assurance and TGRD US project teams in the quality investigation, deviation and waiver process including root cause analysis, remediation, tracking and documentation. This position works closely across multiple functional areas in TGRD US to mitigate compliance risks identified internally through CAPAs and internal audits, and those identified through the PDD Quality Systems Regulatory Intelligence process. This position also organizes the preparation for and support of regulatory inspections, and also leads the internal audit program for TGRD US QA.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Lead TGRD US functional area teams as quality investigation, deviation and waiver liaison when quality issues, posing potential compliance risks to Takeda are identified. Advise teams on activities required to mediate further risk.
- Utilizing standard quality management systems tools, conduct root cause analysis of issue and identify tasks for remediation.
- In conjunction with TGRD US functional area teams, assign responsibilities for remediation tasks and due dates.
- Monitor progress of remediation tasks, and adjust schedule as needed to meet compliance and business needs.
- Assess success of proposed corrections. Renegotiate quality investigation mediation with functional teams as needed to reduce current and future regulatory and compliance risk.
- Align improvements made under quality investigation program across existing systems, procedures, and policies.
- Drive timely execution of quality investigation deliverables through monitoring and reporting activity status to case owners and management.
- Interface with management, peers and subordinates to assess and improve the adequacy of the quality investigation process. This includes but is not limited to the remediation of quality deficiencies noted in audits and/or inspections.
- Knowledgable regarding regulations, laws and standards to maintain Takeda process compliance.
- Work with PDD Global Quality Systems and Regional Associate Director, Quality Systems to provide guidance in interpreting government regulations, agency guidelines and TGRD internal policies in general and specific to quality investigations to assure compliance.
- Deliver quality investigation process training as required to ensure the appropriate level of CAPA process knowledge is maintained throughout organization.
- Support regulatory authority inspections as needed.
- Bachelor’s degree required.
- Minimum 7 years Quality Assurance experience in pharmaceutical industry.
- In-depth knowledge of Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidance’s and Computer System Validation.
- Development: Extensive knowledge of, processes and techniques used to execute a clinical development program.
- Science Knowledge: Possess the necessary science education and knowledge to understand GxP issues related to clinical trials and marketed products.
- Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be proficient in the necessary professional presentation skills, deliver fair/-balanced presentations and, when applicable, facilitate resolution of differing opinions.
- Project Management: Must be able to manage all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Organizational skills: Must be highly flexible and able to prioritize work effectively to meet timelines.
- Interpersonal: Must be highly adept at adapting to other multi-cultural/ personalities in a respectful manner that is conducive to goal achievement and team building.
- Experience with quality tools and process improvement techniques
- Computer skills: 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.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 25 % travel.
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