Assoc Director, BI&T Compliance & CSV
$176.72k - $214.14kScorpion Therapeutics
Duties/Responsibilities Lead the Campus IT Compliance and Computer System Validation (CSV) team; promote safe/compliant mindset; select/develop/coach/manage team; set goals and KPIs; ensure critical projects delivered on time. Act as liaison between site stakeholders and enterprise/business application teams to maintain business continuity. Manage service providers and ensure alignment with contractual SLAs. Act as the onsite Computer System Validation (CSV) process owner; guide site groups on CSV implementation; analyze/address process deficiencies; support Data Integrity and Quality Risk Management programs. Lead campus-wide IT compliance support and project execution: ensure support for GxP business operations; define/track SLAs; collaborate with Digital Plant leaders to reduce support volumes; drive adoption of standard processes/systems (including ServiceNow); maintain GxP documentation compliance/audit readiness; ensure validation/implementation/change management of regulated IT systems in line with regulations; track project progress; provide updates via dashboards. Pursue innovative solutions by reviewing/specifying/revising regulated IT systems; apply industry trends; evaluate vendor recommendations/lessons learned. Requirements / Qualifications Bachelor's degree (Engineering/IT/CS or related) + minimum 12 years in pharma quality/compliance/CSV/IT compliance roles. Proven leadership managing regulated IT compliance/validation; strong coaching/mentoring. Expertise in 21 CFR 210, 211, 11 and GAMP standards; strong CSV/qualification principles. Knowledge of quality principles, system development lifecycles, ISO 9001/QA methodologies. IT oversight experience for electronic systems supporting GMP; ability to work with US FDA and other regulators. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO, ICH. Documentation/technical writing; troubleshooting; creative problem-solving; ability to lead locally and across the network. Benefits Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k), disability, life/accident insurance, supplemental health, business travel protection, legal support, survivor support; paid time off. Compensation Devens, MA, US: $176,720-$214,137. Application instruction If the role doesn't perfectly match your resume, apply anyway. #J-18808-Ljbffr Scorpion Therapeutics
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