Director, IT R&D Assurance and Compliance

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.

The Director of IT R&D Assurance and Compliance manages IT GCP/GLP/CRO/RWE Assurance and Compliance at ProKidney. The primary focus will be ensuring that all IT R&D system technology deliverables meet regulatory requirements and high-quality standards, adhere to industry best practices, and meet/exceed internal customer expectations. The Director of IT R&D Assurance and Compliance is crucial in driving a quality culture, continuous improvement, and technology innovation within the ProKidney IT organization.

As a leader, this role must ensure that quality technical and documentation controls of Prokidney R&D IT systems are effectively in place for phase III investigational new drugs (investigational medicinal products) to meet all quality requirements and regulatory standards and continuous clinical supply and delivery expectations leading to commercialization.

Essential Duties & Responsibilities:

• Lead and oversee the development and implementation of IT assurance and compliance processes, methodologies, and standards for the organization's R&D IT systems.
• Execute a comprehensive assurance and compliance strategy for the organization's R&D information technology initiatives, aligning it with overall business objectives and IT goals.
• Execute assurance and compliance processes and methodologies, ensuring they are tailored to the organization's specific R&D system needs and comply with relevant regulatory requirements.
• Oversee the testing and assurance of the organization's R&D IT systems, applications, and software to identify defects, verify functionality, and ensure they meet performance benchmarks and business and user requirements.
• Drive a culture of continuous improvement within IT, promoting best practices, implementing lessons learned, and optimizing processes to enhance overall system quality and efficiency.
• Utilize a risk-based approach to ensure IT/ technical computing controls impacting patient safety, product quality, and data integrity are documented.
• Identify potential risks and vulnerabilities within the organization's R&D IT systems and develop risk mitigation strategies to ensure data security, operational stability, and business continuity.
• Collaborate with suppliers and external partners to assess their performance and adherence to service level agreements (SLAs) in delivering the organization's R&D IT Systems.
• Work closely with R&D and other business teams to align IT assurance and compliance efforts with project timelines and objectives.
• Partner with Clinical Quality to ensure IT R&D systems compliance with current U.S. and EU cGMP regulations and industry standards and guide business functions on actions necessary to ensure compliance.
• Assist with all IT assurance and compliance initiatives for internal and third-party hosted computer system implementations.
• Provide business areas guidance on GCP/GLP/CRO/RWE regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements (21 CFR Part 11, EU Annex 11, GDPR).
• Review and approve all assurance deliverables and computer system change controls.
• Identify quality issues/discrepancies and effectively and proactively resolve them diplomatically, flexibly, and constructively.
• Lead and manage complex projects/teams within multi-functional objectives and project timelines and participate in cross-functional projects as the IT R&D CSA SME and leadership role.
• Provide strategies to address compliance gaps or determine enhancements to cross-functional IT R&D systems.
• Identify systems performance or compliance gaps, implement or propose solutions, and solve complex technical problems.
• Establish, educate, and enforce standard IT operating procedures.
• Maintain a state of readiness for and participate in IT audits and inspections as needed.
• Other duties as assigned by manager.
  
  

Education and Experience:

• Required: Bachelor's degree in computer science or engineering with 4+ years of relevant work experience or 10+ years of direct relevant working experience with GxP system technology in the Pharmaceutical, Medical Device, Biologics, or Cell and Gene Therapy Development/Manufacturing.
• Required: 10+ years of experience implementing and validating regulated GxP Clinical and Commercial IT Systems.
• Required: 10+ years of experience in Quality methodologies including but not limited to Risk Assessment, Root Cause Analysis, Investigations, and Change Control.
• Preferred: Experienced using IT systems such as eTMF, SAS, and other IT GCP/GLP/CRO/RWE systems.
• Preferred: Experience and proven track record of success for GxP assurance and compliance oversight of late-stage and commercial biologics drug substance and drug product manufacturing.
  
  

Knowledge, Skills, and Abilities

• Deep understanding of GAMP 5, SDLC, ICH guidelines, 21 CFR Part 11, Annex 11, GDPR, and Data Integrity concepts and controls for computerized systems, including good documentation practices.
• Deep understanding of data integrity principles and security controls including, but not limited to, audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc.
• Excellent communication, collaboration, and leadership skills to interact with diverse stakeholders in building a culture of quality.
• Provide strong management and leadership skills, including establishing clear expectations and developing metrics and KPIs to monitor performance and ongoing activities.
• Project management experience and a solid software development life cycle (SDLC) understanding.
• Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
• Demonstrated experience building and leading exceptional IT GxP Assurance and compliance teams.
• Drive ProKidney's strategy and direction to ensure and sustain compliance with digital solutions and technologies and develop global Assurance CSV/CSA-related standards.
• Knowledge of GMP, GCP, GLP, FDA, and EMA regulatory requirements applicable to Biologics, including Cell/Gene/Viral therapy products.
• Strong analytical, problem-solving, and decision-making skills to drive effective solutions.
• Strong knowledge of current industry trends and the ability to use the latest technologies.
• Strong leadership skills that can thrive in a high throughput environment.
• Successful in mentoring people managers.
• Collaboration / Teamwork / Conflict Management.
• Ability to communicate effectively over teleconference and web-based meetings is necessary.
  
  

Computer Skills:

• Proficiency in Microsoft products, including Outlook, SharePoint, Word, PowerPoint, and Excel.
• MasterControl (Other EMS/LMS/QMS System) administration experience.
• Working knowledge of Information Technology Support principles.
• Working knowledge of Database Management and System Networking principles.
  
  

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.