Head of QC Analytics & Quality Assurance

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

Job summary

Rentschler Biopharma Inc. seeks an experienced QC Analytics leader for our Milford, MA site. This role leads the QC Analytics team, manages people, and drives CAPA and investigations in a GMP environment. The ideal candidate has extensive GMP QC and strong supervisory skills to ensure regulatory readiness.

The position oversees audits, documentation, and continuous improvement in QC metrics, with accountability for quality and timelines in support of client projects.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry or related life science field.
• 15+ years of GMP QC experience with at least 5+ years in management.
• Strong leadership to manage technical and lab personnel.
• Knowledge of FDA/EU/ICH regulations related to QC testing and validation.

Responsibilities

• Lead QC Analytics team and laboratory activities.
• Hire and develop employees; set clear expectations for success.
• Provide coaching and drive CAPA, deviations, OOS/OOT investigations.
• Represent QC in audits and regulatory inspections; support documentation.
• Manage data verification, records, and PO processes; drive productivity.

Skills

Leadership

Project management

Communication

GMP knowledge

Education

Bachelors/Masters in Chemistry or Biochemistry

Tools

Quality systems

Job description

Rentschler Biopharma Inc. seeks an experienced QC Analytics leader for our Milford, MA site. This role leads the QC Analytics team, manages people, and drives CAPA and investigations in a GMP environment. The ideal candidate has extensive GMP QC and strong supervisory skills to ensure regulatory readiness.

The position oversees audits, documentation, and continuous improvement in QC metrics, with accountability for quality and timelines in support of client projects.