Overview
On Site
$96 - $96.64 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
INFORMATION TECHNOLOGY
IT
VALIDATION
COMPLIANCE
REGULATORY
SAP
PHARMACEUTICAL
PHARMA
BIOTECH
LIFESCIENCES
LIFE SCIENCES
LIFE-SCIENCES
Job Details
Payrate: $96.00 - $96.64/hr.
Summary:
The Senior IT Quality Assurance (Validation and Compliance) is responsible for defining and executing the validation and qualification strategy for Gapp Computerized Systems, Computerized Equipment, and Infrastructure during the project phase.
Responsibilities:
Minimum Qualification:
Pay Transparency: The typical base pay for this role across the U.S. is: $96.00 - $96.64/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Summary:
The Senior IT Quality Assurance (Validation and Compliance) is responsible for defining and executing the validation and qualification strategy for Gapp Computerized Systems, Computerized Equipment, and Infrastructure during the project phase.
Responsibilities:
- Establish and Oversee IT Validation and Qualification Strategy
- Collaborate with validation and QA teams across Boulder, India and Denmark to establish validation and qualification strategies, and oversee their implementation for GxP Computerized Systems, Computerized Equipment, and Infrastructure in alignment with the Quality Management System.
- Continuously monitor and assess the effectiveness of validation processes, providing recommendations for enhancements as needed.
- Guarantee that documentation related to validation activities is thorough, accurate, and compliant with regulatory requirements.
- Ensure Compliance with Regulatory Requirements
- Conduct regular reviews of systems to ensure compliance with internal and external regulatory requirements.
- Identify compliance gaps and develop corrective action plans to address these issues.
- Stay updated on changes in regulatory requirements and adjust compliance strategies accordingly.
- Provide guidance and support to teams on compliance-related matters.
Minimum Qualification:
- Bachelor's Degree from an accredited university or equivalent education with 10+ years of experience required.
- Strong subject matter expertise in IT validation and compliance.
- Experience developing and executing Validation and qualification strategies for GxP Computerized Systems, Computerized Equipment & Infrastructure.
- Solid understanding of GxP regulatory requirements.
- Ability to apply subject matter knowledge to solve common business issues independently.
- Validation experience with SAP is preferred.
Pay Transparency: The typical base pay for this role across the U.S. is: $96.00 - $96.64/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.