ElevateBio

1 month ago

Director, Quality Systems & Compliance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Lead and transform Quality Systems into a digitally enabled, data-driven, compliant ecosystem supporting clinical through commercial operations; drive AI-enabled quality solutions, regulatory readiness, and enterprise system adoption while partnering with IT, Data/AI, and business leaders to improve efficiency and transparency.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Director level

Key Responsibilities

•Quality Systems Leadership: Lead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection Management.
•Digital System Ownership & AI Enablement: Serve as Business System Owner for eQMS, DMS, and LMS; drive optimization through automation, analytics, and AI use cases.
•Quality System Adoption & Value Realization: Influence enterprise-wide adoption of Quality Systems and translate regulatory requirements into efficient solutions.
•Quality–IT–Digital Integration: Interface between Quality, IT, and Data/AI teams to translate business needs into scalable digital solutions and integrate with SAP, LIMS, MES.
•Operational Excellence & Transformation: Drive process simplification, standardization, and cycle-time improvements; track system effectiveness and adoption.

Pay and Benefits

Salary: USD 190,000 - 260,000 annually

Key Requirements

•12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance.
•Demonstrated experience as a Business System Owner / Digital Process Owner in a GxP environment.
•Strong expertise in global GxP regulations and ability to translate requirements into practical solutions.
•Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES); experience with Veeva Vault is preferred.
•Experience driving digital transformation, automation, and advanced analytics initiatives; familiarity with AI/ML tools.

Experience:12+ yearsBiopharmaceuticalHealthcareBiotech

Skills:LeadershipRegulatory knowledgeDigital transformationAI enablementData-driven decision making

Languages:English

Tech Stack:EQMSDMSLMSSAPLIMSMESVeeva VaultAIMLAutomation

Company Brief

ElevateBio

Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn

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ElevateBio

1 month ago

Director, Quality Systems & Compliance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Director level

Key Responsibilities

•Quality Systems Leadership: Lead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection Management.
•Digital System Ownership & AI Enablement: Serve as Business System Owner for eQMS, DMS, and LMS; drive optimization through automation, analytics, and AI use cases.
•Quality System Adoption & Value Realization: Influence enterprise-wide adoption of Quality Systems and translate regulatory requirements into efficient solutions.
•Quality–IT–Digital Integration: Interface between Quality, IT, and Data/AI teams to translate business needs into scalable digital solutions and integrate with SAP, LIMS, MES.
•Operational Excellence & Transformation: Drive process simplification, standardization, and cycle-time improvements; track system effectiveness and adoption.

Pay and Benefits

Salary: USD 190,000 - 260,000 annually

Key Requirements

•12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance.
•Demonstrated experience as a Business System Owner / Digital Process Owner in a GxP environment.
•Strong expertise in global GxP regulations and ability to translate requirements into practical solutions.
•Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES); experience with Veeva Vault is preferred.
•Experience driving digital transformation, automation, and advanced analytics initiatives; familiarity with AI/ML tools.

Experience:12+ yearsBiopharmaceuticalHealthcareBiotech

Skills:LeadershipRegulatory knowledgeDigital transformationAI enablementData-driven decision making

Languages:English

Tech Stack:EQMSDMSLMSSAPLIMSMESVeeva VaultAIMLAutomation

Company Brief

ElevateBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn