Head Of Quality Control & Quality Assurance

QC Supervisor – Investigations & Compliance

Location: Newton, MA

Department: Quality Control

Position Summary

STC Biologics is seeking a QC Supervisor – Investigations & Compliance to provide technical and operational leadership for QC quality investigations and environmental monitoring activities.

This position will lead and oversee OOS, OOT, deviations, environmental monitoring excursions, CAPA, and change controls, ensuring investigations are scientifically sound, risk-based, thoroughly documented, and completed in accordance with applicable GMP requirements.

Key Responsibilities

Lead and oversee OOS/OOT and QC deviation investigations, including root-cause analysis, impact assessment, and technical conclusions.

Manage investigation of environmental monitoring excursions, including trending, root-cause evaluation, and corrective actions.

Develop and oversee CAPAs, including effectiveness checks and identification of recurring/systemic issues.

Support and lead QC change controls, including risk assessments and evaluation of impacts to methods, equipment, procedures, and computerized systems.

Review investigation reports and provide technical recommendations to QA and QC management.

Trend QC and EM data to identify adverse trends and opportunities for continuous improvement.

Provide technical oversight and day-to-day supervision of QC personnel.

Support regulatory inspections, audits, and inspection readiness activities.

Ensure QC activities comply with applicable cGMP, FDA, ICH, USP, and relevant regulatory requirements.

Collaborate closely with QA, Manufacturing, Process Development, Facilities, and other cross-functional teams.

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.

5+ years of pharmaceutical/biotechnology QC experience, preferably in biologics.

Strong experience with OOS/OOT investigations, deviations, CAPA, change controls, and environmental monitoring.

Demonstrated knowledge of GMP laboratory operations and root-cause investigation techniques.

Strong scientific judgment, technical writing, communication, and problem-solving skills.

Supervisory or leadership experience preferred.

Experience with analytical testing and QC systems supporting biologics manufacturing preferred.

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