QC Data Integrity Lead - Regulatory & Training Champion

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

Benefits offered by this job

Total Rewards package

Discretionary bonus program

Medical insurance

401K program

Job summary

Rentschler Biopharma SE in Milford, MA is seeking a QC Data Integrity Program Manager to implement and maintain data integrity compliance across Quality Control systems, aligning with 21 CFR Part 11, EU Annex 11 and MHRA guidelines.

You will lead training, oversee validation lifecycles for QC software and instruments, coordinate remediation of gaps, and partner across functions to strengthen data governance and regulatory readiness.

Qualifications

• Experience in data integrity and quality oversight of computerized systems.
• Familiarity with regulatory issues and impacts on the discipline.
• Expert knowledge of data integrity principles and applicable regulations.
• Strong project management and ability to lead change.

Responsibilities

• Implement and maintain Data Integrity compliance for QC systems.
• Represent QC data integrity during client and regulatory inspections.
• Manage remediation to identify gaps and implement controls.
• Develop training material and lead training on data integrity.
• Oversee validation lifecycle for QC software/instrumentation.

Skills

Data integrity

Regulatory compliance

Quality oversight

GxP knowledge

Project management

Tools

Empower

SoftMax

ViPER Analytx

LIMS

Job description

Rentschler Biopharma SE in Milford, MA is seeking a QC Data Integrity Program Manager to implement and maintain data integrity compliance across Quality Control systems, aligning with 21 CFR Part 11, EU Annex 11 and MHRA guidelines.

You will lead training, oversee validation lifecycles for QC software and instruments, coordinate remediation of gaps, and partner across functions to strengthen data governance and regulatory readiness.