Senior Manager, Quality

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $160k - $200k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Absci

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• 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

• 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

• 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