Director/Associate Director, Quality Management Systems

Scorpion Therapeutics; United States; Remote; USD 180,000 - 250,000; Full time

Benefits offered by this job

Remote work

Travel opportunities

Job summary

Scorpion Therapeutics is seeking a leader to drive global QMS functions in a biopharma manufacturing context, ensuring compliance, inspection readiness, and ongoing improvement.

The role oversees document control, training, CAPA, deviations, change control, and risk management, leads eQMS validation, supports regulatory inspections, and embeds quality in business processes while tracking system performance; remote with monthly travel to Norwood, MA.

Qualifications

• Bachelor/Master/Doctorate in Life Sciences.
• 10+ years in GxP biotech/pharma.
• Expertise with FDA/EMA/MHRA regulations.
• eQMS validation/maintenance and audit experience.

Responsibilities

• Oversee document control, training, CAPA, deviations, change control, and risk management.
• Manage end-to-end lifecycle of quality documentation.
• Lead implementation and validation of eQMS.
• Support regulatory inspections and audits.
• Embed quality in business processes and drive system performance metrics.

Skills

GxP regulations

Audit experience

Cross-functional collaboration

Education

Life Sciences degree (BSc/MSc/PhD)

Tools

Veeva

MS Office

Job description

Role

Lead global Quality Management System (QMS) functions, ensuring compliance, inspection readiness, and continuous improvement within a biopharma manufacturing setting.

Responsibilities

• oversee document control, training, CAPA, deviations, change control, and risk management;
• manage end-to-end lifecycle of quality documentation;
• lead implementation and validation of eQMS;
• support regulatory inspections and audits;
• embed quality in business processes and drive system performance metrics.

Requirements

• BSc/MSc/PhD in Life Sciences, 10+ years in GxP biotech/pharma, expertise with GxP regulations (FDA, EMA, MHRA), eQMS validation/maintenance, and audit experience.

Preferred

• proficiency in Veeva and MS Office tools;
• demonstrated leadership in inspection management;
• ability to influence cross-functional teams;
• about 5-12% travel.

High-Value

• focus on inspection readiness, regulatory compliance, system validation, and continuous quality improvement aligned with global standards.

Work Setup

• remote with monthly travel to Norwood, MA.