Director, QC Analytics & Data Integrity

Rentschler Biopharma SE

Milford (MA)

On-site

USD 180,000 - 210,000

Full time

9 days ago

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Job summary

Rentschler Biopharma SE seeks a Director of Quality Control - Analytics to lead the QC Analytics team, ensuring timely testing of samples and data integrity to support GMP manufacturing and product disposition. You will supervise a laboratory, manage OOS/OOT investigations, and drive continuous improvement while aligning with regulatory expectations.

The role requires 15+ years in GMP QC, 5+ years in management, and a chemistry/biochemistry life-science background.

Qualifications

  • Bachelor's or Master's degree in Chemistry, Biochemistry or a related life science field.
  • Extensive hands-on quality control and GMP experience preferred.
  • Strong leadership, project management, and cross-functional collaboration skills.

Responsibilities

  • Lead QC Analytics team and laboratory activities.
  • Oversee investigations (OOS/OOT), deviations and CAPA within QC.
  • Represent QC in audits and regulatory inspections; ensure data integrity.

Education

Bachelor's or Master's degree in Chemistry or Biochemistry or related life science field

Job description

Rentschler Biopharma SE seeks a Director of Quality Control - Analytics to lead the QC Analytics team, ensuring timely testing of samples and data integrity to support GMP manufacturing and product disposition. You will supervise a laboratory, manage OOS/OOT investigations, and drive continuous improvement while aligning with regulatory expectations.

The role requires 15+ years in GMP QC, 5+ years in management, and a chemistry/biochemistry life-science background.

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