Executive Director, QMS & Digital

Scorpion Therapeutics; Waltham (MA); On-site; USD 240,000 - 360,000; Full time

Benefits offered by this job

401(k) with match

Parental leave (12 weeks)

Organs & marrow leave (12 weeks)

Equity incentives

Medical/dental/vision

Life & disability insurance

Flexible time off

Winter shutdown

Holidays

Job summary

Scorpion Therapeutics in Waltham, MA is seeking a senior Quality leader to own the QMS strategy, governance, and continuous improvement across the organization.

You will drive enterprise quality processes, CAPA, change control, and deviations, while building a modern data-driven QMS with CSV oversight.

Qualifications

• Bachelor’s degree required with 15+ years in quality within life sciences.
• 8+ years GMP experience; deep QMS strategy/governance expertise.
• Experience maintaining inspection-ready QMS and leading inspections/audits.
• Experience in digital transformation, data analytics, and CSV in regulated environments.

Responsibilities

• Own the strategy, governance, effectiveness, compliance and continuous improvement of the QMS.
• Serve as enterprise Quality owner for QMS governance, processes, and frameworks (document control, training, CAPA, change control, deviations).
• Lead Quality Process Excellence to simplify/standardize processes while ensuring compliance.
• Develop and execute Quality digital strategy/roadmap and automation with IT/stakeholders.
• Own Quality metrics and data infrastructure enabling actionable insights and proactive management.
• Provide oversight for CSV, data integrity, and lifecycle management of Quality systems.
• Lead and develop a high-performing team; partner for inspections, audits, and external assessments.

Skills

QMS governance

Leadership

Regulated environments

Quality data analytics

Strategic planning

Influence stakeholders

Change leadership

Risk management

Education

Bachelor’s degree

Advanced degree preferred

Job description

Position Summary

• Own and be accountable for the strategy, governance, effectiveness, compliance, and continuous improvement of the Company’s Quality Management System (QMS), ensuring it operates as an integrated, reliable, and scalable system.
• Serve as enterprise Quality owner for QMS governance, processes, and frameworks for document control and training, CAPA, change control, quality events and deviations, and process excellence.
• Own digital and data capabilities enabling a modern QMS, including Quality digital and AI strategy, Quality metrics and data infrastructure, and computerized system validation (CSV). Lead/develop teams and partner across the organization.

Responsibilities

• Own overall QMS performance: compliance, effectiveness, reliability, inspection readiness, continuous improvement.
• Lead core QMS processes: document control/training, CAPA, change control, quality events/deviations.
• Establish governance and performance management using risk, metrics, trends, and management review.
• Lead Quality Process Excellence to simplify/standardize/optimize processes while maintaining compliance.
• Develop and execute Quality digital strategy/roadmap and automation (with IT and stakeholders).
• Own Quality metrics and data infrastructure to enable actionable insights and proactive management.
• Provide oversight for CSV, data integrity, and compliant lifecycle management of Quality systems.
• Lead and develop a high-performing team; serve as senior Quality partner for inspections, audits, and external assessments.

Qualifications

• Bachelor’s degree (advanced degree preferred). 15+ years Quality experience in life sciences; 8+ years GMP experience.
• Deep QMS strategy/governance expertise and core QMS processes (document management, training, CAPA, change control, deviations/quality events, investigations, management oversight).
• Knowledge of global GxP; experience maintaining inspection-ready QMS and supporting/leading inspections and audits.
• Experience in Quality process excellence, digital transformation, Quality data/analytics, regulated technology environments (CSV, data integrity).
• Understanding of responsible AI use in regulated environments (governance, risk, validation, compliance).
• Proven leadership and ability to influence stakeholders and translate strategy into measurable execution.
• Strong systems thinking, judgment, communication, and change leadership; ability to balance compliance, risk, operational effectiveness, technology, and business needs.
• Travel up to 20%.

Benefits

• 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; equity incentive plans; medical/prescription/dental/vision; life insurance and disability; flexible time off; Winter Holiday shutdown; at least 11 paid holidays.