Associate Director, Development Quality – OSD

Scorpion Therapeutics; Conshohocken (Montgomery County); On-site; USD 140,000 - 220,000; Full time

Benefits offered by this job

Flexible paid time off

Medical/dental/vision insurance

401(k) offerings

Job summary

Scorpion Therapeutics is seeking a senior Program QA leader to guide quality strategy for oral development programs, ensuring phase-appropriate oversight, risk management, and inspection readiness across internal teams and external partners.

You will own governance cadence, develop program quality plans, and partner with CMC and clinical supply to evolve control strategies, with a track record of cross-functional leadership and QA excellence.

Qualifications

• BS+ Life Sciences / Engineering (or related)
• 10-12 years QA experience with development-stage oversight
• Demonstrated cross-functional leadership and risk-based judgment

Responsibilities

• Own quality strategy, governance cadence, and risk register for assigned oral programs; define and track readiness milestones
• Guide application of QMS processes (deviations/CAPA/change control) in development context and ensure timely closure
• Produce deliverables such as program quality plans, readiness trackers, and decision/action logs
• Oversee external vendors/CMOs supporting oral development activities; ensure governance and escalation pathways
• Maintain inspection-ready documentation, narratives, and evidence packages for program scope
• Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes

Skills

Cross-functional leadership

Risk-based judgment

Quality risk management

Change management

Executive communication

Veeva Vault Quality

Education

BS in Life Sciences / Engineering

Tools

Veeva Vault Quality (eQMS)

Job description

Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones; ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management.

Key Responsibilities

• Program QA Leadership (Oral)
  • Own quality strategy, governance cadence, and risk register for assigned oral programs; define and track readiness milestones
  • Guide application of QMS processes (deviations/CAPA/change control) in development context and ensure timely closure
  • Produce deliverables such as program quality plans, readiness trackers, and decision/action logs
• Partner Oversight & Inspection Readiness
  • Oversee external vendors/CMOs supporting oral development activities; ensure governance and escalation pathways
  • Maintain inspection-ready documentation, narratives, and evidence packages for program scope
  • Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes

Required Qualifications

• BS+ Life Sciences / Engineering (or related)
• 10-12 years QA experience with development-stage oversight
• Demonstrated cross-functional leadership and risk-based judgment

Preferred Qualifications

• Experience in pharmaceutical/biotech oral product development and clinical supply interfaces
• Experience with external development networks and inspection support

Key Competencies

• Development QA governance, phase-appropriate oversight, and readiness milestone management
• Change management (impact assessment, stakeholder mapping, communications, training/SOP readiness, adoption measurement)
• Partner governance/performance management across CMOs/vendors; inspection readiness evidence discipline
• Cross-functional leadership, escalation, and executive-ready risk/decision communication
• Quality risk management, issue triage, and timely action closure
• Veeva Vault Quality (eQMS) proficiency

Benefits

• Flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) offerings; supplemental voluntary benefits; mental health benefits via Employee Assistance Program.