Associate Director, QMS Operations

Scorpion Therapeutics; Waltham (MA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Hybrid work model

Travel up to 10%

Job summary

Scorpion Therapeutics seeks an Associate Director, QMS Operations to oversee key QMS processes within a regulated biotech/pharma environment, including Deviations, CAPA, complaints, and Change Control. The role emphasizes process standardization, risk monitoring, and cross-functional collaboration to sustain compliance.

You will drive continuous improvement, oversee investigations, and support regulatory audits, with a focus on GxP adherence and QMS enhancements in a fast-paced setting.

Qualifications

• Bachelor's in scientific or engineering discipline.
• 8–10 years quality experience in regulated life sciences with Deviations, CAPA, investigations, and regulatory standards.
• Proven experience as a process owner or in enterprise quality initiatives.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Establish process standards.
• Drive continuous improvement.
• Ensure compliance with GxP and regulatory requirements.
• Oversee investigations and root cause analysis.
• Monitor KPIs and trends to identify risks.
• Partner cross-functionally with Quality, Manufacturing, Supply Chain, and Regulatory teams.
• Support audits and inspections.
• Lead process harmonization and electronic QMS enhancements.

Skills

GxP compliance

Deviations

CAPA

root cause analysis

investigations

cross-functional collaboration

regulatory standards

analytical skills

communication skills

Education

Bachelor's degree in scientific or engineering discipline

Job description

Role

Associate Director, QMS Operations, overseeing key Quality Management System processes such as Deviations, CAPA, Complaints, and Change Control within a biotech/pharma environment.

Responsibilities

• establish process standards
• drive continuous improvement
• ensure compliance with GxP and regulatory requirements
• oversee investigations and root cause analysis
• monitor KPIs and trends to identify risks
• partner cross-functionally with Quality, Manufacturing, Supply Chain, and Regulatory teams
• support audits and inspections
• lead process harmonization and electronic QMS enhancements

Requirements

• Bachelor's in scientific or engineering discipline
• 8-10 years in quality within regulated life sciences, with strong expertise in Deviations, CAPA, investigations, and regulatory standards
• proven experience as a process owner or in enterprise quality initiatives
• excellent analytical, problem-solving, and communication skills

Preferred

• advanced degree
• experience supporting regulatory audits
• risk management capabilities

HighValue

• GxP compliance
• Deviations
• CAPA
• root cause analysis
• regulated biopharma (pharma/biotech)
• process optimization
• cross-functional collaboration

Work Setup

hybrid (2-3 days onsite Waltham, MA); travel up to 10%.