Senior Quality Engineer – GMP & Supplier Quality Leader

Ferring Pharmaceuticals; Minneapolis (MN); Presencial; USD 94.000 - 174.000; Jornada completa

Descripción de la vacante

Ferring Pharmaceuticals in Roseville, Minnesota, seeks a Sr. Quality Engineer to provide QA support under minimal supervision for biologic therapeutics, ensuring cGMP and global regulatory compliance.

You will guide supplier-related changes, validations, CAPA, audits, and quality system improvements. Ideal candidate has a Bachelor's in science and 7+ years in GMP quality roles, with pharma experience and strong data-driven decision making.

Formación

• Minimum 7 years’ experience in GMP Quality roles.
• Minimum 3 years’ experience in pharmaceutical industry.
• Demonstrated experience in problem solving, root cause analysis and risk management methods.
• High proficiency in Outlook, Word, PowerPoint, and Excel.
• Certified auditor preferred.
• Certified Quality Engineer preferred.
• Experience in computer system validation requirements is a plus.
• Experience in Veeva, SAP, and Trackwise is a plus.

Responsabilidades

• Support supplier management process including supplier qualification, audits, SCARs, and quality agreements.
• Manage materials, parts, and services through a risk-based approach.
• Perform and support internal and external audits.
• Interface with internal departments and regulatory bodies for compliance needs.
• Review and approve Complaint, CAPA, Audit Findings, and Deviation investigations.
• Provide quality system support by updating site procedures and improving processes.
• Participate in third party audits (Notified Body, FDA) as required.
• Escalate Quality issues based on risk and trend analyses.
• Contribute to continuous process improvement and quality culture.
• Provide customer service attitude when interacting with internal and external customers.

Conocimientos

Problem solving

Root cause analysis

Risk management

Effective communication

Technical writing

Data-driven decisions

Educación

Bachelor’s degree in science (chemistry, microbiology or biotechnology)

Herramientas

Veeva

SAP

Trackwise

Descripción del empleo

Ferring Pharmaceuticals in Roseville, Minnesota, seeks a Sr. Quality Engineer to provide QA support under minimal supervision for biologic therapeutics, ensuring cGMP and global regulatory compliance.

You will guide supplier-related changes, validations, CAPA, audits, and quality system improvements. Ideal candidate has a Bachelor's in science and 7+ years in GMP quality roles, with pharma experience and strong data-driven decision making.