Global Quality Compliance Lead

Scorpion Therapeutics; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Scorpion Therapeutics is seeking a senior quality leader to drive strategy and governance across operating units and sites. You will lead global quality councils, interpret trends, and escalate systemic risks while ensuring adherence to QMS and quality plans.

You will influence senior leadership, coordinate cross-functional teams, and own the delivery of quality improvements, CAPA programs, and ongoing inspection readiness across a multi-site biotech environment.

Qualifications

• Requires Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, Quality or related field.
• 10+ years in quality, compliance, quality systems, or regulated manufacturing.
• Strong understanding of QMS governance, risk management, escalation, and quality execution expectations.
• Ability to develop strategy, analyze complex quality data, and translate insights into action.

Responsibilities

• Lead coordination and oversight of quality councils; manage agendas; prepare analyses; track actions and decisions.
• Identify risks and escalation points; assess red metrics; influence senior leaders; provide fact-based recommendations.
• Oversee QMS documents and site feedback for review; assign OpU topic leads; drive standardization/harmonization.
• Track progress against annual Quality Plans; monitor performance; report status; address slippage and constraints.
• Execute quality improvement actions; define scope and success metrics; drive cross-functional accountability.
• Lead global critical compliance projects; build governance plans; ensure sustainable implementation with follow-up.

Skills

Action item mgmt

Data integrity

Continuous improvement

Executive leadership

Global coordination

GMP compliance

Mentoring staff

Operational quality

Performance plans

QMS

Quality metrics

Risk management

Regulatory compliance

Process standardization

Progress monitoring

Quality control

Education

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

Job description

Job Summary

• Drive strategy, execution, and oversight of key quality compliance activities across Operating Units (OpUs) and associated sites.
• Provide leadership for global quality governance forums (GPO, GVO, GBO Quality Councils) and act as a connector between site quality teams, OpU leadership, QMS Topic Leads, and global governance bodies/DQC.
• Operate autonomously to interpret quality trends, identify systemic risks/opportunities, escalating appropriately, monitor execution against annual Quality Plans, and enable consistent implementation of QMS expectations.
• Lead quality improvement activities identified via governance forums, trend analysis, inspection readiness assessments, leadership reviews, and QMS discussions.

Key Responsibilities

• Lead coordination/administration/oversight of GPO, GVO, GBO Quality Councils; manage agendas; prepare executive analyses; track actions and decisions; identify themes and systemic issues.
• Identify risks and recurring failure modes; coordinate escalation with DQC; assess red metrics/commitment-date performance; influence senior leaders; provide fact-based recommendations; serve as trusted escalation point.
• Oversee QMS documents and site feedback for QMSC review; ensure OpU topic leads assigned; translate QMS update challenges into leadership insights; recommend standardization/simplification/harmonization; escalated major implementation concerns.
• Own tracking of progress against annual Quality Plans; monitor performance and delivery risks; provide status updates; identify slippage/dependencies/resource constraints; translate quality strategy into actions/milestones.
• Execute quality improvement actions; define scope/objectives/deliverables/success measures; drive cross-functional accountability and tracking; monitor effectiveness; support continuous improvement and targeted initiatives.
• Lead/support global critical compliance projects; develop plans/governance; monitor and communicate progress; ensure sustainable implementation via ownership/follow-up/metrics; build long-term capability.

Qualifications

• Required
  • Bachelor’s in Life Sciences, Pharmacy, Chemistry, Engineering, Quality, or related.
  • 10+ years in quality, compliance, quality systems, or regulated manufacturing.
  • Strong understanding of QMS governance, risk management, escalation, and quality execution expectations.
  • Ability to develop strategy, analyze complex quality data, and translate insights into action.
  • Proven record influencing senior leaders and cross-functional stakeholders without direct authority.
  • Strong executive communication; ability to lead multiple priorities in ambiguity and drive global accountability.
• Preferred
  • Experience supporting/leading quality councils/governance/executive review forums.
  • Experience driving quality improvement, standardization, or compliance transformation.
  • Familiarity with CAPA, metric trending, quality plan management, inspection readiness.
  • Pharmaceutical/biotech or other highly regulated industry experience.
  • Knowledge of global QMS frameworks across multi-site organizations.

Required Skills (as listed)

• Action item management; compliance activities; data integrity; driving continuous improvement/efficiency improvements; executive leadership/presence; global coordination; GMP compliance; mentoring staff; operational quality; performance plans; QMS; quality metrics/risk management; regulatory compliance; process improvements/standardization; progress monitoring; quality control/management.

Benefits / Application Instructions

• Annual bonus and long-term incentive (if applicable).