Director, QC Analytics & Quality Leadership

Rentschler Biopharma Inc.; Milford (MA); On-site; USD 180,000 - 210,000; Full time

Job summary

Rentschler Biopharma Inc. is seeking a Director of Quality Control - Analytics to lead the QC Analytics team, overseeing testing of materials, intermediates, and products to ensure GMP compliance and timely data for releases.

The role requires 15+ years in GMP QC, with at least 5+ years in leadership, and involves collaboration with QA, manufacturing, and regulatory teams to maintain data integrity and support audits.

Qualifications

• 15+ years of GMP QC experience with 5+ years in managerial roles.
• Leadership to manage technical and laboratory personnel.
• Understanding FDA/EU/ICH regulations related to quality attributes, testing, validation, and transfer.

Responsibilities

• Lead QC Analytics team and laboratory activities.
• Hire and develop department staff with clear expectations.
• Provide active feedback, coaching and employee development.
• Participate in Milford Site Quality Leadership meetings and action plans.
• Collaborate within QC to author, review and approve QC documents per GMP for regulatory submissions and inspections.
• Support OOS/OOT investigations, deviations and CAPA related to QC.
• Represent in customer and regulatory audits and implement corrective actions.
• Oversee data verification, records management, and PO management in QC Analytics.
• Drive continuous improvement to enhance productivity and efficiency in QC.
• Report QC metrics via Quality Management Reviews and Quality Council.
• Promote a strong Quality Culture aligned with company values.

Skills

GMP QC experience

People management

Project management

Strong communication

Cross-functional collaboration

Education

Bachelor's or Master's in Chemistry/Biochemistry or related life science

Job description

Rentschler Biopharma Inc. is seeking a Director of Quality Control - Analytics to lead the QC Analytics team, overseeing testing of materials, intermediates, and products to ensure GMP compliance and timely data for releases.

The role requires 15+ years in GMP QC, with at least 5+ years in leadership, and involves collaboration with QA, manufacturing, and regulatory teams to maintain data integrity and support audits.