Manager, Quality Assurance Compliance

Scorpion Therapeutics; United States; On-site; USD 136,000 - 176,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager/Sr. Manager, Global Supplier Quality to lead the SNA lifecycle, data integrity, and ASL governance across supplier networks. You will coordinate cross-functional assessments, engage suppliers for information, and ensure changes do not compromise product quality or patient safety.

The role emphasizes data-driven governance, continuous improvement, and collaboration with GMP-regulatory teams to meet global standards.

Qualifications

• 4+ years in Quality Assurance/Supplier Quality/Quality Systems/Compliance or related pharma/biotech functions.
• Experience with supplier quality systems, supplier change management, and master data management.
• Experience with quality management systems/enterprise platforms such as Veeva, SAP, GPLM, or equivalent.
• Understanding of GMP, GDP, ICH, FDA, EMA, and global regulatory requirements.
• Strong analytical/critical-thinking and problem-solving skills.
• Ability to manage multiple priorities while maintaining compliance and quality timelines.
• Strong cross-functional collaboration, communication, and stakeholder presentation skills.
• Continuous improvement mindset; Lean Six Sigma Green Belt or higher desirable.

Responsibilities

• Manage Supplier Notification Assessment (SNA) lifecycle from intake through closure; ensure timely, compliant, risk-based evaluation of supplier change notifications.
• Intake review/triage using critical thinking and risk-based decision-making; prioritize and maintain SNA records.
• Coordinate cross-functional impact assessments and action follow-up via status tracking.
• Communicate with suppliers to obtain additional information and documentation.
• Review/summarize impact assessment outcomes; facilitate stakeholder discussions and support decision-making.
• Ensure critical supplier changes do not impact product quality, regulatory compliance, or patient safety.
• Drive improvements to supplier change management governance, visibility, and consistency.
• Support quality metrics/trend/performance indicator generation, analysis, and reporting.
• Support process improvements to streamline and integrate supplier quality processes across the network.

Skills

Quality Assurance

Supplier Quality

Change Management

Master Data Management

Regulatory Knowledge

Analytical Thinking

Critical Thinking

Multitasking

Cross-functional Collaboration

Communication Skills

Presentations

Lean Six Sigma

Tools

Veeva

SAP

GPLM

Job description

Manager / Sr. Manager, Global Supplier Quality

Key Responsibilities

• Manage Supplier Notification Assessment (SNA) lifecycle from intake through closure; ensure timely, compliant, risk-based evaluation of supplier change notifications.
• Intake review/triage using critical thinking and risk-based decision-making; prioritize and maintain SNA records.
• Coordinate cross-functional impact assessments and action follow-up via status tracking.
• Communicate with suppliers to obtain additional information and documentation.
• Review/summarize impact assessment outcomes; facilitate stakeholder discussions and support decision-making.
• Ensure critical supplier changes do not impact product quality, regulatory compliance, or patient safety.
• Drive improvements to supplier change management governance, visibility, and consistency.
• Support quality metrics/trend/performance indicator generation, analysis, and reporting.
• Support process improvements to streamline and integrate supplier quality processes across the network.

Supplier Quality Master Data Management

• SME for supplier quality records across systems; conduct proactive data reviews.
• Manage and coordinate supplier quality master data change requests.
• Collaborate to implement updates and resolve data integrity issues; provide status reporting.
• Lead data remediation/clean-up (inactive supplier reviews, approval status verification, missing data correction, system optimization).

Approved Supplier List (ASL) Management

• Reconcile ASL data against system records for accuracy/compliance.
• Facilitate recurring ASL review meetings.
• Manage/prioritize ASL change requests; support global ASL integration and continuous improvement.

Qualifications & Competencies

• 4+ years in Quality Assurance/Supplier Quality/Quality Systems/Compliance or related pharma/biotech functions.
• Experience with supplier quality systems, supplier change management, and master data management (knowledge of supplier master data requirements).
• Experience with quality management systems/enterprise platforms such as Veeva, SAP, GPLM, or equivalent.
• Understanding of GMP, GDP, ICH, FDA, EMA, and global regulatory requirements.
• Strong analytical/critical-thinking and problem-solving skills; ability to assess impact and prioritize.
• Ability to manage multiple priorities while maintaining compliance and quality timelines.
• Strong cross-functional collaboration, communication, and stakeholder presentation skills.
• Continuous improvement mindset; Lean Six Sigma Green Belt or higher desirable.

Compensation & Benefits

• Salary range: $136,340.00 - $176,440.00.
• May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.