Associate Director Quality Systems

Scorpion Therapeutics; Richmond (VA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Bonus program

401(k) and pension

Medical/dental/vision

Flexible benefits

Life insurance

Job summary

Scorpion Therapeutics seeks an Associate Director Quality Systems to lead GMP compliance, quality systems, and vendor oversight. The role manages QA documentation, deviations, and data integrity while driving continuous improvement.

You will mentor teams, collaborate with internal and external stakeholders, and align activities with corporate GMP goals. The position requires a robust quality background, leadership experience, and strong regulatory knowledge to maintain biopharmaceutical

Qualifications

• BS in Pharmacy, Science, Engineering, or related discipline.
• 8+ years quality assurance experience in relevant manufacturing.
• 4+ years leadership experience with direct reports.

Responsibilities

• Oversee GMP compliance activities and approve quality documents.
• Lead quality systems improvements and vendor management.
• Provide QA systems leadership and training resources.
• Support site strategy and capital/project planning aligned to GMP.

Skills

Quality Assurance

Leadership

Regulatory knowledge

Data Integrity

Education

BS in Pharmacy, Science, Engineering

Tools

TrackWise

Kneat

DCS

DeltaV

Job description

Associate Director Quality Systems

Key Responsibilities

• GMP Compliance: Escalate critical quality issues per site Notification to Management procedure; review and approve quality documents (e.g., Vendor Management, Service Providers, Document Control); review and approve deviations and quality-related documents (e.g., QA e-systems, QA procedures, change controls).
• Quality Systems And Customer Focus: Implement improvements within quality systems; supervise Vendor management reps, QA E-Systems rep, and Document Control; collaborate with internal teams and customers to improve quality systems; resolve quality issues pertaining to E-Systems and vendor management.
• Technical Excellence: Provide tools/resources for QA systems and compliance unit; provide technical leadership/advice for key quality issues; develop and maintain report training, performance management plans, reviews, career plans; support assignments/workload management.
• Corporate/Site Strategy And Mission: Support expense/capital/headcount/project business planning aligned to GMP and compliance requirements.

Minimum Qualifications

• BS in Pharmacy, Science, Engineering, or related discipline.
• 8+ years quality assurance experience in relevant manufacturing.
• 4+ years leadership experience with direct reports.

Additional Skills/Preferences

• Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management, and biopharmaceutical regulatory requirements.
• Quality Systems experience (required).
• Excellent problem-solving/analytical skills; detail-oriented; strong communication/teamwork; proactive continuous improvement.
• Plus: TrackWise; automation systems (e.g., Kneat, DCS, DeltaV).

Additional Requirements/Information

• Travel: 0–20% initially; intra-site travel required.
• Ability to work with internal/external stakeholders and field incoming requests timely.

Benefits (as stated)

• Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.