Associate Director, Quality Assurance (Drug Substance/Drug Product)

Associate Director, Quality Assurance (Drug Substance/Drug Product)

Associate Director, Quality Assurance to assist in the overall management of end-to-end GxP quality activities for NAP manufacturing programs specifically focusing on Drug Substance and Drug Product. Primary responsibilities will be to ensure quality and compliance of NAP’s development and commercial programs with respect to QMS management, controlled documents, and applicable regulatory requirements (FDA/ICH/EMEA, and current industry standards and practices) are conducted in a compliant manner. The team operates in a highly collaborative, results‑oriented, and fast‑paced environment, requiring a hands‑on mindset and strong cross‑functional engagement. This is a remote position and will report to the Senior Director, QA/QC.

Key Responsibilities:

Manufacturing Quality

• 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

• Ensure CMO quality systems, processes, specifications, and SOPs are appropriate for clinical and commercial manufacturing, release and distribution of quality product meeting relevant regulatory requirements, applicable standards and guidance

• Serve as the primary QA point of contact for external manufacturing sites, contract labs, and suppliers.

• 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

• Assist in evaluation and escalation (as appropriate) of product quality issues. Ensure timely and effective follow-up of all identified or assigned quality issues

• 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

• Review and verify data to ensure compliance with data integrity and regulatory requirements, as appropriate

• Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approving relevant documents per program timelines and associated Health Authority (HA) information requests, as required

• Assist in generation, tracking and trending of manufacturing quality compliance metrics and compile metrics and information for Quality Management Team reports

• For the EU, work with the selected EU Designated Person to ensure Good Distribution Practices.

Quality Systems:

• Develop, review and approve GxP controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions, and supporting documents related to GxP activities

• Assist in phase appropriate oversight of systems and optimize systems as they move from clinical to commercial phases

• Assist in coordination and conduct of routine and non-routine quality assurance audits including: CROs/vendors, process, system, and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines; this will include conducting audits

• Participate in internal audits to identify areas of improvement and collaborate with stakeholders to implement effective and sustainable corrective measures

• Support related activities in preparation for HA inspections and support interactions during HA inspections

• Continuously improve and maintain Quality Systems related to GxP activities, maintain documentation for compliance with quality and regulatory standards

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