Senior Manager, Quality

Scorpion Therapeutics; Marlborough (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager, Quality at its Marlborough site to strengthen quality systems, drive continual improvement, and foster a quality-centric culture. You will oversee ISO 9001, audits, CAPA, validation, and document control; lead a growing quality team; monitor KPIs; and drive digital transformation toward electronic systems while partnering with global stakeholders.

This leadership role requires strategic vision for compliance in biopharma manufacturing and a

Qualifications

• Bachelor's in Chemistry, Biology, Engineering, or related field.
• 10+ years in regulated quality environments (ISO 9001, ISO 13485, cGMP).
• 4+ years of leadership experience coaching and developing teams.
• Expertise in QMS, audits, CAPA, validation, and document control.
• Strong knowledge of GDP, root cause analysis, and quality investigations.

Responsibilities

• Oversee ISO 9001 compliance, audits, CAPA, document control, and validation.
• Lead and develop quality team members.
• Monitor quality metrics and KPIs.
• Support audit programs.
• Manage investigations and nonconformances.
• Lead digital transformation initiatives to transition to electronic systems.
• Collaborate with global quality stakeholders and site leadership to implement enterprise-wide quality processes.
• Promote continuous improvement and risk-based decision making.

Skills

QMS

Audits

CAPA

Validation

Document control

GDP

Root cause analysis

Quality investigations

Leadership

Digital transformation

Education

Bachelor's in Chemistry, Biology, Engineering, or related field

Job description

Role

Senior Manager, Quality responsible for strengthening quality systems, driving continual improvement, and fostering a quality-centric culture at the Marlborough site.

Responsibilities

• oversee ISO 9001 compliance, internal/external audits, CAPA, document control, and validation
• lead and develop quality team members
• monitor quality metrics and KPIs
• support audit programs
• manage investigations and nonconformances
• lead digital transformation initiatives to transition to electronic systems
• collaborate with global quality stakeholders and site leadership to implement enterprise-wide quality processes
• promote continuous improvement and risk-based decision making

Qualifications

• Bachelor's in Chemistry, Biology, Engineering, or related field
• 10+ years in regulated quality environments (ISO 9001, ISO 13485, cGMP)
• 4+ years of leadership experience in coaching and developing teams
• expertise in QMS, audits, CAPA, validation, and document control
• strong knowledge of GDP, root cause analysis, and quality investigations

Preferred

experience with digital quality system transformation, lean or operational excellence methodologies.

High-value

strategic quality leadership within biopharma manufacturing, supporting biologics or other biologic modalities, with a focus on compliance, continuous improvement, and digitalization.

Work setup

not specified, but involves cross-functional partnership and leadership.