Life Sciences Validation and Compliance Lead
Req ID:
129393
NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.
We are currently seeking a Life Sciences Validation and Compliance Lead to join our team in Plano, Texas (US-TX), United States (US).
Life Sciences Validation and Compliance Lead and SME to lead a global program in support of new logo pursuits, management of matrixed staff supporting clients, developing training to enhance knowledge across the company, and representing NTT in front of clients related to capabilities, credentials, and delivery acumen.
Job Responsibilities Include:
- Knowledge of Validated System requirements with experience leading and managing IQ/OQ/PQ FDA regulatory process
- Knowledge of CFR Part 11 compliance for medical device and pharma processes
Skills - Skilled in discussing client compliance programs and identifying gaps, areas for improvement, and how NTT can support
- Skilled in forming Life Science industry points of view through writing articles, developing and leading training, and validating delivery teams adhere to the program
- Ability to write proposals, RFPs, and SOWs and discuss with clients
- Ability to set a direction and lead a matrixed team to understand, learn, and adhere while managing change control for managed services
- Willingness to form client relationships directly in support of program delivery, demand forecasting, and generating growth
- Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements
Basic
Qualifications:
- Minimum of 8 years experience in validation and compliance.
- Minimum of 8 years in business consulting.
- Minimum of 3 years of healthcare and life sciences experience.
About NTT DATA Services
NTT DATA Services is a global business and IT services provider specializing in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services. We are part of the NTT family of companies, a partner to 85 % of the Fortune 100.
NTT DATA Services is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, gender, disability, age, veteran-status, sexual orientation, gender identity, or any other class protected by law.
Estimated Salary: $20 to $28 per hour based on qualifications.
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