Associate Director, Quality Assurance – Drug Substance/Drug Product
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Job Description
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.
Responsibilities:
- 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:
- 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:
- Health insurance
- Dental and vision coverage
- Term life and disability coverage
- Retirement plans
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