Data Integrity Program Lead, QC & Compliance

Rentschler Biopharma; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Rentschler Biopharma is seeking a QC Data Integrity Program Manager to lead Data Integrity compliance activities within Quality Control and to represent the company during client and regulatory inspections. The role requires extensive expertise in regulatory data integrity requirements and validation of QC computerized systems.

You will develop training materials, manage remediation efforts for data gaps, and collaborate cross-functionally to ensure data integrity across Empower, Softmax, ViPER

Qualifications

• 8+ years of relevant/relatable experience in data integrity, quality oversight of computerized system management/validation, QA compliance/regulatory and/or similar areas of focus
• Must be familiar with use of electronic data management and laboratory information management
• Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
• Thorough knowledge of regulatory issues and the impacts on discipline
• Expert knowledge on industry data integrity principles and applicable regulations such as 21 CFR Part 11, EU Annex 11, MHRA GxP Data Integrity Requirements
• Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines
• Excellent organization and planning skills
• Strong attention to detail and ability to adhere to standards procedures
• Strong project management skills and ability to lead effective change management are desired
• Strong understanding of Computerized System validation principals
• Ability to drive functional, technical, and operational excellence
• Working understanding of applicable QC computerized systems and how they interact such as Empower, Softmax, ViPER Analytx, and other similar software
• Good understanding of the complexity, interactions, and dynamics within an international company
• Experience supporting client or regulatory audits as it applies to Data Integrity

Responsibilities

• Implement and maintain Data Integrity compliance activities for all Quality Control systems in alignment with relevant regulatory regulations and guidelines
• Represent Rentschler as the QC subject matter expert during client and regulatory inspections related to data integrity
• Manage remediation efforts to identify data integrity gaps and risks and implement appropriate technical and procedural controls as required
• Provide oversight of data integrity compliance for software and instrument validation lifecycle activities associated with QC computerized systems to ensure conformance to GxPs, guidance documents, applicable industry standards, and Rentschler business practices
• Develop training material and lead training efforts with SMEs as it relates to Data Integrity principals and best practices
• Effectively manage and execute strategic business opportunities to improve business processes
• Provide day to day oversight for the governance, management and coordination of activities in QC related to Data Integrity
• Work cross functionally with other departments to provide, support, guidance, and feedback on applying appropriate Data Integrity controls and best practices
• Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions

Skills

Data integrity

Quality oversight

Computerized systems

Regulatory compliance

GxP knowledge

21 CFR Part 11

EU Annex 11

Project management

Audit support

Attention to detail

Tools

Empower

Softmax

ViPER Analytx

Job description

Rentschler Biopharma is seeking a QC Data Integrity Program Manager to lead Data Integrity compliance activities within Quality Control and to represent the company during client and regulatory inspections. The role requires extensive expertise in regulatory data integrity requirements and validation of QC computerized systems.

You will develop training materials, manage remediation efforts for data gaps, and collaborate cross-functionally to ensure data integrity across Empower, Softmax, ViPER