Senior Manager, Quality

Absci

. Support the buildout and implementation of a robust Quality Management System .

Posted 9/17/2026full-timeRemote • United StatesSenior💰 $160,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Quality Management System (QMS) ownership and improvement, with a strong focus on compliance with GCP, GMP, and GLP standards. Proven ability to manage audits, vendor qualifications, and cross-functional partnerships to ensure quality foundations in biotech or pharma environments.

Highest-signal resume keywords

Quality Management System OwnershipGCP, GMP, GLP ExperienceFDA/EMA Inspection ManagementTeam Building and LeadershipISO Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Standards DefinitionSOP DevelopmentCAPA ManagementDeviation HandlingChange Control ProcessesRisk-Based MindsetQuality OversightBiologics ManufacturingCell Line DevelopmentComputer System Validation

Soft Skills

Cross-Functional CollaborationRelationship BuildingEffective CommunicationSenior Individual Contributor

Tools & Technologies

Veeva QMSQuality Management Software

Industry Keywords

BiotechPharmaQuality CertificationsRegulatory ComplianceClinical-Stage Biotech

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the buildout and implementation of a robust Quality Management System
Own and continuously improve the QMS, ensuring it is fit-for-purpose and inspection-ready
Define and maintain quality standards, SOPs, and process documentation across GCP, GMP, and GLP environments
Lead and manage internal and external audits
Manage CRO/CMO vendor qualification and ongoing oversight
Partner with Regulatory to support submission requirements and agency inspections
Oversee CAPA management, deviation handling, and change control processes
Champion quality certifications and ensure compliance with relevant ISO standards
Build relationships across R&D, Clinical, Manufacturing, IT, and Legal
Partner cross-functionally to build quality foundations early in workflows
Opportunity to build a team as Absci scales

Requirements

What you’ll need

8+ years of quality experience in biotech or pharma
Hands-on exposure across at least two of GCP, GMP, or GLP
Bachelor's degree in life sciences, chemistry, or a related field
Direct experience managing or supporting FDA and/or EMA inspections
Hands-on QMS ownership, including building or rebuilding a quality system
Risk-based mindset and ability to balance rigor with speed
Prior experience at Manager or Director level
Comfort and effectiveness as a senior individual contributor
Legal authorization to work in the United States
Preferred: experience with quality oversight in cell line development, biologics manufacturing, or similar modalities
Preferred: experience with Veeva QMS
Preferred: familiarity with AI/ML quality considerations or computer system validation (CSV/CSA)
Preferred: experience in a clinical-stage biotech building quality infrastructure from an early stage

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Unlimited vacation
Parental leave
Employee assistance program
Voluntary life insurance
Disability insurance
Annual bonus potential
401(k) with a generous company match
Equity