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

About the role

NewAmsterdam Pharma (NAP) is an innovative biotech company dedicated to developing life-saving treatments for lipid-related diseases. The Associate Director, Quality Assurance will play a crucial role in ensuring compliance with global GxP regulations and guiding cross-functional teams throughout the drug lifecycle.

Responsibilities

• 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.
• 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.
• Aid in evaluating and escalating (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.
• 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.
• Develop, review and approve GxP controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions, and supporting documents related to GxP activities.
• Aid in phase appropriate oversight of systems and optimize systems as they move from clinical to commercial phases.
• Aid 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 auditsto 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