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Associate Director Quality Systems
Job in
Richmond, Henrico County, Virginia, 23214, USA
Listed on 2026-09-12
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-12
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering, Data Analyst
Job Description & How to Apply Below
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.
- BS in Pharmacy, Science, Engineering, or related discipline.
- 8+ years quality assurance experience in relevant manufacturing.
- 4+ years leadership experience with direct reports.
- 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:
Track Wise; automation systems (e.g., Kneat, DCS, DeltaV).
- Travel: 0–20% initially; intra-site travel required.
- Ability to work with internal/external stakeholders and field incoming requests timely.
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Position Requirements
10+ Years
work experience
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