More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
Computerized Systems Quality Assurance (CS QA) Leader helps deliver on Takeda s commitments for patient safety, product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare laws and regulations, and Takeda policies and procedures. The CS QA Leader also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.
- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
- Promote and champion support of compliance, quality and best practice oriented culture regarding computerized systems.
- Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests
- Support the development of global CS QA related procedures
- Participate in ongoing operational management activities for global systems including but not limited to demand management, Change Advisory Board and Quality Metrics
- Conduct audits of global computerized system vendors and 3rd party software providers, including SaaS
- Provide expertise and support during audits and inspections of Takeda
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Proactively identify risks and issues. Drive implementation of pragmatic, compliant, quality based solutions.
- Lead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned
- Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data
- Plan, execute and report on internal audits of activities, records and processes related to regulated computerized systems and regulated data
- Support the response and remediation of corrective actions and internal audits.
Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor degree in Science, Business, Engineering, IT or related discipline or 5 years equivalent professional experience.
- Minimum 6 years experience with FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements.
- Minimum 4 years experience working with IT systems and teams
- Experience making quality assurance and compliance decisions in regards to software development, validation and support.
- Experience with all phases of software validation and infrastructure qualification.
- Experience with all phases of System Development Lifecycles principles, processes and procedures.
- Demonstrated multitasking project management and execution skills
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
- Ability to read, analyze and interpret business plans, technical procedures, and government regulations
- Proven analytical and problem resolution skills; ability to identify root cause of problems
- Excellent verbal and written communication skills at the functional and technical level.
- Ability to understand complex business processes and recommend simplification where possible.
- Documented experience in working as part of a "virtual team.
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio).
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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