Senior Manager, Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the development and execution of a comprehensive Quality Management System.

• Take ownership of the QMS and drive ongoing enhancements to ensure it is appropriately designed and ready for inspections.

• Establish and uphold quality standards, SOPs, and process documentation within GCP, GMP, and GLP environments.

• Lead and coordinate both internal and external audit processes.

• Oversee the qualification and continuous monitoring of CRO/CMO vendors.

• Collaborate with the Regulatory team to facilitate submission requirements and agency inspections.

• Manage CAPA processes, deviation resolutions, and change control activities.

• Advocate for quality certifications and guarantee compliance with applicable ISO standards.

• Foster relationships across R&D, Clinical, Manufacturing, IT, and Legal departments.

• Work collaboratively across functions to establish quality foundations early in workflows.

• Opportunity to create a team as Absci grows.

⛳️ Requirements

• A minimum of 8 years of quality experience within the biotech or pharmaceutical sector.

• Practical experience in at least two of GCP, GMP, or GLP environments.

• A Bachelor’s degree in life sciences, chemistry, or a related discipline.

• Direct involvement in managing or supporting FDA and/or EMA inspections.

• Proven experience in QMS ownership, including the establishment or revitalization of a quality system.

• A risk-based perspective with the ability to balance thoroughness and efficiency.

• Previous experience in a Manager or Director role.

• Ability to work effectively as a senior individual contributor.

• Legal authorization to work in the United States.

• Preferred: experience in quality oversight within cell line development, biologics manufacturing, or comparable areas.

• Preferred: familiarity with Veeva QMS.

• Preferred: understanding of AI/ML quality considerations or computer system validation (CSV/CSA).

• Preferred: experience in a clinical-stage biotech setting, establishing 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.