Associate Director, Quality Assurance – Drug Substance/Drug Product

NewAmsterdam Pharma Corporation

Associate Director of Quality Assurance managing drug substance and product quality at NewAmsterdam Pharma. Ensuring compliance with regulations and collaborating with cross-functional teams in a remote position.

Posted 7/11/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Assist in the overall management of end-to-end GxP quality activities for NAP manufacturing programs focusing on Drug Substance and Drug Product.
Ensure quality and compliance of NAP’s development and commercial programs with respect to QMS management, controlled documents, and applicable regulatory requirements.
Responsible for GxP (GMP, GCP, GLP, GVP) quality and guidance to cross functional teams for late stage through commercial drug lifecycle development.
Ensure compliance with all applicable global GxP regulations and guidelines.
Conduct Quality review and approval of vendor master and executed batch records, stability protocols, validation protocols/reports, and analytical protocols, methods and reports.
Conduct product release of drug substance, drug product, packaged and labeled product
Drive quality activities for internal and external Change Controls assessing product quality and regulatory impact.
Provide Quality review and approval for deviations, complaint investigations, and OOS/OOTs, assessing for product quality and program impact.
Partner with internal and external stakeholders to drive issue resolution, CAPA identification and ensure timely closure.

Requirements

What you’ll need

Bachelor's degree in scientific discipline, advanced degree a plus
6-8 years in the pharmaceutical industry, with a minimum of 6 years in Quality
Solid understanding of GxP standards, policies, and procedures (domestic and international)
Demonstrated experience and understanding of small molecule drug substance and non-sterile oral solid dosage drug product manufacturing
GMP vendor auditing experience a strong plus
Experience in commercial launch and product is preferred.
Experience working with CMOs
Excellent verbal and written communication skills
Collaborative problem-solver, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
Ability to travel domestically and internationally, approx. 20% of the time

Benefits

Comp & perks

Health insurance
Dental and vision coverage
Term life and disability coverage
Retirement plans

ATS Keywords

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Hard Skills & Tools

GxP StandardsQuality Management System (QMS)Drug Substance ManufacturingNon-Sterile Oral Solid DosageChange Control ManagementDeviation InvestigationAnalytical ProtocolsValidation ProtocolsProduct Release ProcessesCAPA Identification

Soft Skills

Excellent Communication SkillsCollaborative Problem-SolverAnalytical SkillsIndependent WorkAdaptability