QMS Global Quality Compliance Director

Scorpion Therapeutics; Wilmington (DE); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical/dental/vision

401(k)

Paid holidays

Vacation

Sick days

Job summary

Scorpion Therapeutics in Wilmington, DE seeks a senior leader to own QC governance, QMS oversight, and cross-functional quality initiatives across global sites.

You will drive risk management, CAPA programs, and executive reporting, ensuring compliance with GMP and regulatory readiness.

This role requires 10+ years in quality/compliance within regulated manufacturing, with strong leadership and strategic influence.

Qualifications

• Bachelor’s degree in life sciences or related field with 10+ years in quality/compliance in regulated manufacturing.
• Proven governance, risk/escalation expertise and senior stakeholder influence.
• Global, ambiguity-tolerant priority management and executive communication.

Responsibilities

• Lead coordination and oversight of Quality Councils, manage agendas and executive analyses.
• Assess quality risk signals and ensure proper escalation to decision makers; drive leadership interventions.
• Oversee QMS documents for QMSC review and coordinate topic assignments for governance.
• Own annual Operating Unit Quality Plan progress, monitor performance and resources.
• Lead quality improvement activities from audits, inspections, and leadership reviews.
• Drive global critical compliance projects with governance, metrics, and cross-functional teams.

Skills

QMS governance

Risk management

Executive communication

Global coordination

Continuous improvement

Data integrity

GMP compliance

Quality metrics

Cross-functional leadership

Stakeholder influence

Education

Bachelor’s in Life Sciences/Pharmacy/Chemistry/Engineering/Quality or related

Tools

QMS systems

Job description

Key Responsibilities

• Lead coordination, administration, and oversight of GPO, GVO, and GBO Quality Councils; manage agendas; prepare executive analyses; track actions and decisions; identify systemic themes and elevate.
• Partner to assess quality risk signals and recurring failure modes; ensure correct escalation to DQC; use red-metric trends/commitment-date performance to determine leadership intervention; influence senior leaders; provide fact-based recommendations; act as escalation point for major QMS/site readiness/quality execution issues.
• Provide integrated oversight of QMS documents for QMSC review; coordinate OpU assignment for QMS topics; translate QMS update challenges into leadership insights; recommend standardization/simplification/harmonization; elevate major implementation concerns.
• Own tracking of annual Operating Unit Quality Plan progress; monitor performance, slippage, dependencies, and resources; provide status updates.
• Lead execution of quality improvement activities from councils/trends/audits/inspections/leadership reviews; define scope/objectives/success measures; drive cross-functional execution and monitor effectiveness.
• Lead/support global critical compliance projects; manage cross-function/geography initiatives; establish governance, plans, and metrics.

Qualifications

• Required: Bachelor’s in Life Sciences/Pharmacy/Chemistry/Engineering/Quality or related; 10+ years in quality/compliance/quality systems/regulated manufacturing; strong QMS governance & risk/escalation understanding; ability to analyze complex quality data and turn insights into action; proven senior stakeholder influence without direct authority; strong executive communication; global, ambiguity-tolerant priority management.
• Preferred: Quality council/governance forum experience; quality improvement/standardization/compliance transformation; CAPA/metric trending/quality plan/inspection readiness familiarity; pharma/biotech regulated experience; global QMS frameworks.

Required Skills

• Action item management, compliance activities, QMS, quality metrics & risk management, GMP compliance, executive leadership/presence, global coordination, continuous improvement, data integrity, performance plan/progress monitoring, process standardization & improvement.

Benefits

• Eligible for annual bonus and long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.