Associate Director, Quality Assurance – Drug Substance/Drug Product

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

📋 Description

• Support the comprehensive management of end-to-end GxP quality activities for NAP manufacturing initiatives, concentrating on Drug Substance and Drug Product.

• Ensure that NAP’s development and commercial programs adhere to quality and compliance standards in relation to QMS management, controlled documents, and relevant regulatory requirements.

• Accountable for GxP (GMP, GCP, GLP, GVP) quality oversight and guidance to cross-functional teams throughout the late-stage and commercial drug lifecycle development.

• Guarantee compliance with all pertinent global GxP regulations and guidelines.

• Perform quality reviews and approvals for vendor master files and executed batch records, stability protocols, validation protocols/reports, and analytical protocols, methods, and reports.

• Execute product release for drug substance, drug product, packaged, and labeled products.

• Lead quality initiatives for both internal and external Change Controls, evaluating product quality and regulatory implications.

• Provide quality review and approval for deviations, complaint investigations, and OOS/OOTs, assessing their impact on product quality and programs.

• Collaborate with internal and external stakeholders to facilitate issue resolution, identify CAPA, and ensure timely resolution.

⛳️ Requirements

• Bachelor’s degree in a scientific field; an advanced degree is an advantage.

• 6-8 years of experience in the pharmaceutical sector, with at least 6 years focused on Quality.

• Strong comprehension of GxP standards, policies, and procedures (both domestic and international).

• Proven experience and knowledge in the manufacturing of small molecule drug substances and non-sterile oral solid dosage forms.

• GMP vendor auditing experience is highly desirable.

• Experience with commercial product launches is preferred.

• Familiarity with working alongside CMOs.

• Outstanding verbal and written communication skills.

• A collaborative problem-solver capable of analyzing complex issues to formulate relevant and practical plans, programs, and recommendations.

• Ability to continuously prioritize tasks and work independently, as part of a cross-functional team, and with external vendors with minimal guidance.

• Willingness to travel domestically and internationally, approximately 20% of the time.

🏝️ Benefits

• Health insurance

• Dental and vision coverage

• Term life and disability coverage

• Retirement plans