External Quality Assurance Lead

Rentschler Biopharma SE; Milford (MA); Presencial; USD 120.000 - 165.000; Jornada completa

Descripción de la vacante

Rentschler Biopharma SE in Milford, MA is seeking an External Quality Assurance Supervisor to lead the QA function in a fast-paced CDMO setting. You will supervise personnel, escalate quality issues, and coordinate with clients to ensure compliance with regulatory requirements and internal procedures.

The role requires deep knowledge of FDA cGMP, QA systems, and readiness for client audits. Strong leadership, communication, and problem-solving skills are essential for continuous improvement

Formación

• Bachelor’s Degree in STEM or related discipline is required.
• 7+ years of experience in the Quality function within a biotech or pharmaceutical company or other regulated industry.
• Experience leading, mentoring, or coordinating others in a quality environment.
• Strong knowledge of FDA cGMP regulatory requirements in biologics manufacturing.
• Experience with electronic quality systems including data mining, reporting, and query building.

Responsabilidades

• Supervise External Quality Assurance personnel, assign work, train, and prioritize deliverables.
• Serve as escalation point for complex quality issues and ensure timely resolutions.
• Provide QA oversight and act as liaison between QA and clients for programs and quality matters.
• Review and approve quality documents and records for compliance with client requirements and regulatory expectations.
• Support inspection readiness activities and participate in client audits and regulatory inspections.

Conocimientos

Quality leadership

Risk-based decision making

Communication skills

Data analysis

Attention to detail

Cross-functional collaboration

Educación

Bachelor’s Degree in STEM or related discipline

Herramientas

Excel

Electronic quality systems

CAPA software

Descripción del empleo

Rentschler Biopharma SE in Milford, MA is seeking an External Quality Assurance Supervisor to lead the QA function in a fast-paced CDMO setting. You will supervise personnel, escalate quality issues, and coordinate with clients to ensure compliance with regulatory requirements and internal procedures.

The role requires deep knowledge of FDA cGMP, QA systems, and readiness for client audits. Strong leadership, communication, and problem-solving skills are essential for continuous improvement