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Apply online for the
Electronic QA Senior Project Manager
position and advance your career in the
Pharmaceutical industry today.
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Electronic QA Senior Project Manager : Takeda Pharmaceutical
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| Employee Type |
Full Time |
| Company Name |
Takeda Pharmaceutical |
| Location |
Deerfield
Illinois
60015 |
| Salary (year) |
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| Industry |
Pharmaceutical |
| Job Type |
Quality-Assurance |
| Required Degree |
Bachelors of Engineering |
| Certifications |
Software Quality Engineer Certification |
| Relocation |
Not Required |
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Takeda Pharmaceutical
View all jobs from Personified |
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| Apply online at company website |
| Description |
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As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. We are a research-based company, enhancing our R&D pipeline by concentrating our management resources. Takeda's in-house ethical drugs are marketed in around 90 countries worldwide and are recognized as the brand leader in major countries worldwide. Our management philosophy, "Takeda-ism" is the basis of our business as we continue to grow and prosper.
Takeda is an energetic company that attracts and retains well-qualified personnel from all over the world. We strive to maximize the capabilities of our work force by creating a corporate climate that is appealing and encouraging to skilled and ambitious individuals. This will entail preparation of a global personnel program that, first and foremost, fairly evaluates and rewards employees for the results they achieve.
Job Description
We are currently seeking an EDQA Senior Project Manager to manage the regulated electronic data quality assurance (EDQA) compliance efforts both within Takeda and at Takeda-contracted manufacturing vendors, research sites, laboratories, data hosting sites and application service providers. Major components of EDQA activities include:
• Develop and execute implementation plans for EDQA global, regional, and company-wide strategic initiatives
• Assist in the development of and ensure the execution of EDQA policies, procedures, practices, and standards
• Oversight of software validation activities for Takeda with primary emphasis on global systems, projects, and strategies
• Development and implementation of a Global strategy for compliance to Electronic Record/Electronic Signature regulations Establishment, implementation, and management of internal and external EDQA audit programs.
• Working in collaboration with Takeda global organizations and business groups develop that support Takeda business needs for creation, use, transmission, and storage of electronic data at global, regional, group, and site levels.
• Develop processes and tools to manage the execution of EDQA tasks that support the creation, analysis, and reporting of quality metrics that measure performance drive continuous improvement.
• Develop and implement training programs that provide guidance and direction for the execution of computer system validation processes, tools and techniques to Takeda technical, business, and quality groups from a global perspective.
• Assist in establishing the TPNA EDQA Group as a Global Center of Excellence for Takeda Affiliates in the areas of system development, validation, data integrity, and system reliability.
• Assist in the maintenance of Takeda’s Electronic Data, Systems, and Services Quality and Compliance Master Plan and communicate the plan with IT, Legal, and Takeda organizations that serve as system owners/users or sponsors external data systems or services
• Develop and implement strategies, processes, tools and techniques to identify areas for improvement within the electronic data, systems, and services environment, and implement action plans for implementing improvements. Work with IT, Legal, and Takeda business organizations as appropriate to effectively execute action plans.
• Lead and participate in cross-functional activities to integrate information and systems that may have a quality or regulatory impact. |
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| Requirements |
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• Bachelor’s Degree required preferably in Computer Science, Engineering or related technical field. Master’s Degree in Quality Assurance, Computer Science, Software Engineering, is preferred.
• Preferrably ASQ and SQA certified.
• 8 years minimum experience (12+ years preferred) combined experience in pharmaceutical, healthcare or medical devices in software quality assurance, software development and validation.
• 5+ years’ management/supervisory experience.
• 10 or more years experience in a regulated software development/validation environment.
• 8 or more years experience in leading software validation efforts or providing SQA direction and guidance.
• 6 or more years Quality Assurance and auditing experience.
• Excellent analytical and problem-solving skills
• Ability to provide guidance on validation of computer systems.
• Ability to balance regulatory compliance requirements with project timelines and business unit expectations.
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
Preferred Background/Skills:
• Master’s/MBA Degree in Quality assurance, computer science, software engineering, or related field
• ASQ certification in Software Quality Engineering or Quality Auditing
Integrity in All That We Do!
Takeda's basic human resource principal is to "develop a high-performance, results-oriented culture within our organization with motivated employees who take pride in and find a sense of accomplishment from their work."
To that end, we provide a comprehensive compensation and benefits package designed to promote the health and happiness of our valued employees and their families!
Submit your resume today and start a quality career with Takeda! |
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| Contact Info |
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Kristy Wojnicki |
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Apply online at company website |
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