Global Quality Compliance Lead

Scorpion Therapeutics; Pennsylvania; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401(k)

Paid holidays and vacation

Job summary

Scorpion Therapeutics seeks a senior Quality governance leader to coordinate cross-functional quality councils and drive systemic improvements. You will oversee risk signals, CAPA strategies, and escalation paths across the site, partnering with QMS leads and OpU leadership to align on priorities and resources.

You will influence senior leaders with data-driven analyses, manage QMS documents, and guide global compliance initiatives, ensuring readiness for inspections and sustained GMP compliance.

Qualifications

• Action item management and compliance execution responsibilities.
• Data integrity and quality risk management are core.
• Experience with GMP, QMS governance, and inspections is required.

Responsibilities

• Coordinate and lead Quality Councils; manage agendas, analyses, and action tracking.
• Identify cross-functional themes and systemic quality issues; escalate appropriately.
• Partner with QMS leads to assess risk signals and escalation paths.
• Evaluate red metric trends and resource needs; influence leadership on priorities.
• Oversee QMS documents and site feedback for QMSC reviews; align OpU leads to topics.
• Track progress against annual Operational Unit Quality Plans; monitor performance and resources.
• Lead quality improvement activities from governance, audits, and leadership reviews.
• Lead/global critical compliance projects with broad OpU impact.

Skills

Action item management

Compliance activities

Data integrity

Quality risk management

GMP compliance

QMS

Quality metrics

Education

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

Job description

Key Responsibilities

• Coordinate and lead GPO, GVO, and GBO Quality Councils; manage agendas, executive analyses, and action tracking.
• Identify cross-functional themes and systemic quality issues; elevate appropriately.
• Partner with QMS Topic Leads and site/OpU leaders to assess risk signals, recurring failure modes, and escalation paths.
• Evaluate red metric trends, commitment-date performance, and recurring issues; influence senior leaders on priorities, resourcing, timelines, and corrective actions.
• Provide oversight of QMS documents and site feedback for QMSC review; align OpU leads to QMS topics.
• Track progress against annual Operating Unit Quality Plans; monitor performance, slippage, dependencies, and resources.
• Lead quality improvement activities from governance, trend analysis, audits/inspections, and leadership reviews.
• Lead/support global critical compliance projects with broad OpU impact.

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 management, escalation, and quality execution knowledge; strategic analysis and executive communication.

Preferred:

• Experience with quality councils/governance forums.
• CAPA/metric trending/quality plan management/inspection readiness experience; regulated industry experience (e.g., pharma/biotech); global QMS framework knowledge.

Required/Preferred Skills (as listed)

• Action item management, compliance activities, data integrity, quality risk management, GMP compliance, QMS, quality metrics, process standardization, progress monitoring, driving continuous improvement.

Benefits

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