Associate Director, Quality Assurance – Drug Substance/Drug Product

🕒 Julho 11

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NewAmsterdam Pharma Corporation

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $175.300.000 Post IPO equity em 2024-03

Healthcare • Biotechnology • Pharmaceuticals

A NewAmsterdam Pharma Corporation é uma empresa biofarmacêutica em estágio clínico, focada no desenvolvimento de terapias para doenças cardiovasculares e outras condições relacionadas aos lipídios. A empresa está avançando com o obicetrapib, um inibidor de CETP, e outros programas destinados a reduzir o LDL-C e diminuir o risco cardiovascular para pacientes que têm necessidades não atendidas, apesar dos tratamentos redutores de lipídios existentes. A NewAmsterdam enfatiza o desenvolvimento baseado em ciência, ensaios clínicos e iniciativas focadas no paciente.

Descrição

• 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.

🎯 Requisitos

• 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

🏖️ Benefícios

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