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Data Integrity Site Lead

New York, NY 10153

Posted: 01/26/2023 Employment Type: Contract To Hire Job Category: Technology Job Number: 540837 Is job remote?: No Country: United States

Job Description

Data Integrity Site Lead
Hybrid in New York, NY
$85-$105/hr


The CSA Lead is a key thought leader and stakeholder in the ELC Center of Excellence (COE). The primary function of this role is to provide quality and compliance guidance to CSA projects (sometimes simultaneously) as a coach and mentor. This expert is responsible for leading and managing CSA projects while communicating with business leaders and team management, directing, and scheduling resources, and ensuring consistency across validation project teams. The CSA Lead must ensure validation projects meet regulatory and data integrity requirements, and they must confirm validation projects meet R&D/GSC/IT policies.

Responsibilities:
• Ensure the overall CSA strategy and provide end-to-end guidance on validation efforts to the COE team.
• Partner with business stakeholders to translate, analyze, and define requirements, providing solutions and project milestones, specific to CSA validation
• Partner with business stakeholders to develop an understanding of the business strategy, ensuring that the program infrastructure is managed to provide agreed upon levels of service
• Oversee CSA project delivery and COE personnel, maintaining consistent high-quality service and validation/qualification excellence
• Interpret data and perform analysis, translate policy and regulatory requirements
• Lead validation teams in the use of efficient, innovative approaches while remaining compliant with regulatory and business requirements
• Continuously learn and evolve their expertise in the CSA model, approaches, and methodologies to provide the highest level of coaching/mentoring for COE members and project teams
• Review Supplier Assessments

Qualifications:
• Bachelor’s Degree in Computer Science, Information Systems, or related field
• One or more relevant industry certifications and an active membership in ISPE
• 15+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance
• Experience working in regulated environments with demonstrable experience ensuring software compliance with industry best practices and FDA standards
• Expertise in risk management principles, strong change control processes, and practice with testing tools within an Agile environment
• Mastery of GAMP 5 and 21 CFR Part 11 standards
• Solid understanding of software development life cycle (SDLC)
• Familiarity with ISO 62304, ISO 13485, and ISO 14791
• Deep experience with Data Integrity and ALCOA+
• Competency with project management practices and techniques

Skills:
• Excellent relationship building skills with the ability to build quick rapport while earning trust through demonstrated practical expertise and a strong commitment to accountability with deliverables
• Superior written and verbal communication skills
• Superior ability to communicate with executive leadership in an effective and concise manner
• Strong analytical and problem-solving abilities
• Strong ability to lead and delegate responsibilities within the team
• Ability to self-direct and complete project deliverables within established timelines
• Works well in a fast-paced environments with an eye toward balancing the right priorities to achieve maximum quality outcomes on behalf of ELC
• Understands purpose of CSA, passionate about customer safety, data integrity, and product quality
• Adept at solution development and project scoping
• Effectively collaborate with peers, cross-functional teams, and departments
• Strong technical background is preferred
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