External Quality Assurance Lead – Biotech & CDMO

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

Rentschler Biopharma Inc. is seeking a Supervisor, External Quality Assurance to provide hands-on leadership for the external QA function in a fast-paced CDMO environment.

You will supervise personnel, set priorities, coordinate workload, and ensure quality deliverables meet client expectations and regulatory requirements. The successful candidate will balance tactical execution with long-term process improvements and partner cross-functionally to manage quality risks in biologics manufacturing.

Qualifications

• Bachelor’s degree in STEM or related discipline.
• 7+ years in quality within biotech/pharma or similarly regulated industry.
• Experience leading or coordinating others in a quality environment.
• Strong knowledge of FDA cGMP in a biologics setting.
• Experience with electronic quality systems, data mining, reporting, and querying.

Responsibilities

• Lead and coach External Quality Assurance personnel and prioritize deliverables.
• Be primary escalation point for complex quality issues and client requests.
• Provide QA oversight and communicate with customers for assigned programs.
• Represent QA on cross-functional teams and align quality expectations.
• Review and approve documents and reports for new product introduction and lifecycle QC.
• Lead SOP development and maintain quality systems documentation.
• Monitor quality metrics and drive continuous improvement initiatives.
• Support training and ensure regulatory readiness including audits.

Skills

Leadership

Quality systems

cGMP knowledge

Data analysis

Communication

MS Office

Biologics manufacturing

Risk assessment

Education

Bachelor's Degree in STEM

Tools

LIMS

EDMS

Excel

Job description

Rentschler Biopharma Inc. is seeking a Supervisor, External Quality Assurance to provide hands-on leadership for the external QA function in a fast-paced CDMO environment.

You will supervise personnel, set priorities, coordinate workload, and ensure quality deliverables meet client expectations and regulatory requirements. The successful candidate will balance tactical execution with long-term process improvements and partner cross-functionally to manage quality risks in biologics manufacturing.