Data Integrity QC Program Lead – Quality & Compliance

Rentschler Biopharma, Inc.; Milford (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Rentschler Biopharma, Inc. in Milford, MA is seeking a Data Integrity Program Manager for Quality Control to implement and maintain data integrity compliance across QC systems.

The role involves leading training, managing remediation to close gaps, and ensuring alignment with global regulatory requirements. As a senior SME, you will drive governance of data integrity activities, collaborate cross-functionally, and author essential quality documentation to support continuous quality and

Qualifications

• 8+ years of data integrity and QA compliance experience.
• Familiar with electronic data management and laboratory information management.
• Experience with deviations, change controls, SOPs and GMP guidelines.
• Strong knowledge of 21 CFR Part 11, EU Annex 11 and MHRA GxP data integrity.
• Excellent project management, organization and cross-functional collaboration.

Responsibilities

• Implement and maintain Data Integrity compliance for QC systems per regulations.
• Represent QC as SME during client and regulatory inspections related to data integrity.
• Manage remediation to identify gaps and implement controls.
• Oversee data integrity across software/instrument validation lifecycle for QC systems.
• Develop training material and lead training with SMEs on data integrity best practices.
• Govern QC Data Integrity activities and drive process improvements.
• Collaborate cross-functionally to apply data integrity controls and best practices.
• Author quality system docs: change controls, deviations, CAPAs, SOPs, work instructions.

Skills

Data Integrity

QA Compliance

Computerized System Validation

Regulatory Knowledge

Project Management

Tools

Empower

ViPER Analytx

Softmax

LIMS

Job description

Rentschler Biopharma, Inc. in Milford, MA is seeking a Data Integrity Program Manager for Quality Control to implement and maintain data integrity compliance across QC systems.

The role involves leading training, managing remediation to close gaps, and ensuring alignment with global regulatory requirements. As a senior SME, you will drive governance of data integrity activities, collaborate cross-functionally, and author essential quality documentation to support continuous quality and