R&D Quality Strategy Lead — Shape Global Patient Outcomes

EMD Serono, Inc.; Billerica (MA); In loco; USD 142.000 - 213.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Paid time off

Retirement contributions

Perquisites

Descrizione del lavoro

EMD Serono, Inc. in the United States is seeking a strategic R&D Quality Strategy Lead to drive quality strategy across development programs and ensure risk management and inspection readiness.

You will partner with cross-functional teams and senior leaders to embed quality into development decisions. The role emphasizes program quality governance, due diligence support, and continuous improvement, with on-site work in Billerica, MA.

Competenze

• Bachelor's degree in a scientific or quality-related field; advanced degree preferred.
• 10+ years of experience in Quality Assurance or related pharmaceutical/biotech field.
• Strong knowledge of drug development processes and global GCP regulations.

Mansioni

• Lead Program Quality Strategy and develop the quality strategy for assigned development programs.
• Define and oversee risk assessments, program audit strategy and QA activities.
• Provide quality expertise during due diligence and key business decisions.
• Support continuous improvement and quality-by-design approaches across programs.
• Drive risk mitigation strategies and oversee deviation management.
• Lead inspection preparedness activities and support health authority inspections.
• Monitor audits, track deliverables and promote consistent quality practices.
• Collaborate with Clinical Development, Regulatory Affairs, and other R&D functions.

Conoscenze

Quality Assurance

GxP & regulations

Stakeholder management

Project leadership

Formazione

Bachelor's degree in science/quality

Strumenti

GxP systems

QA audit tools

Descrizione del lavoro

EMD Serono, Inc. in the United States is seeking a strategic R&D Quality Strategy Lead to drive quality strategy across development programs and ensure risk management and inspection readiness.

You will partner with cross-functional teams and senior leaders to embed quality into development decisions. The role emphasizes program quality governance, due diligence support, and continuous improvement, with on-site work in Billerica, MA.