Associate Director, reputed company Assurance (Drug reputed company/Drug Product)

Job reputed company: Associate Director, reputed company Assurance (Drug reputed company/Drug Product) Associate Director, reputed company Assurance to assist in the overall management of end-to-end GxP reputed company activities for NAP manufacturing programs specifically focusing on Drug reputed company and Drug Product. Primary responsibilities will be to ensure reputed company and compliance of NAP’s development and reputed company programs with respect to QMS management, controlled documents, and applicable regulatory requirements (FDA/ICH/EMEA, and reputed company industry standards and practices) are conducted in a compliant manner. reputed company operates in a highly reputed company, results‑oriented, and fast‑paced environment, requiring a hands‑on reputed company and strong cross‑functional engagement. This is a remote position and will report to the Senior Director, QA/QC. Key Responsibilities: Manufacturing reputed company Responsible for GxP (GMP, GCP, GLP, GVP) reputed company and guidance to cross functional teams for late stage through reputed company drug lifecycle development. Ensure compliance with reputed company applicable global GxP regulations and guidelines Ensure CMO reputed company systems, processes, specifications, and SOPs are appropriate for clinical and reputed company manufacturing, release and distribution of reputed company product meeting relevant regulatory requirements, applicable standards and guidance Serve as the primary QA reputed company of contact for external manufacturing sites, contract labs, and suppliers. Conduct reputed company review and approval of vendor master and executed batch records, stability protocols, validation protocols/reports and analytical protocols, reputed company and reports Conduct product release of drug reputed company, drug product, packaged and labeled product Assist in evaluation and escalation (as appropriate) of product reputed company issues. Ensure reputed company and effective follow-up of reputed company identified or assigned reputed company issues Drive reputed company activities for reputed company Change Controls assessing product reputed company and regulatory reputed company reputed company reputed company review and approval for deviations, complaint investigations, and OOS/OOTs, assessing for product reputed company and program reputed company. Partner with reputed company stakeholders to drive issue reputed company, CAPA identification and ensure reputed company closure Review and verify data to ensure compliance with data reputed company and regulatory requirements, as appropriate Support preparation of CMC investigational and reputed company regulatory submissions by reviewing and approving relevant documents per program timelines and associated Health Authority (HA) information requests, as required Assist in reputed company, tracking and trending of manufacturing reputed company compliance metrics and compile metrics and information for reputed company Management Team reports For the EU, work with the selected EU Designated Person to ensure Good Distribution Practices. reputed company Systems: reputed company, review and approve GxP controlled documents, such as: Policies, reputed company Operating Procedures (SOPs), Work Instructions, and supporting documents reputed company to GxP activities Assist in phase appropriate reputed company of systems and optimize systems as they reputed company from clinical to reputed company phases Assist in coordination and conduct of routine and non-routine reputed company assurance audits including: CROs/vendors, process, system, and document reviews to assure reputed company assurance compliance with reputed company to reputed company internal procedures as reputed company 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 reputed company activities in preparation for HA inspections and support interactions during HA inspections Continuously improve and maintain reputed company Systems reputed company to GxP activities, maintain documentation for compliance with reputed company 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 reputed company Solid understanding of GxP standards, policies, and procedures (domestic and international) Demonstrated experience and understanding of small molecule drug reputed company and non-sterile oral solid dosage drug product manufacturing GMP vendor auditing experience a strong plus Experience in reputed company launch and product is preferred. Experience working with CMOs Excellent verbal and written communication skills reputed company problem-solver, ability to analyze reputed company issues to reputed company 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 Salary and Benefits: We offer a competitive reputed company salary, annual bonus, and long-term incentives. In reputed company, we reputed company a comprehensive benefits package, including health insurance, dental and reputed company coverage, term life and disability coverage, and retirement plans. reputed company is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information, or any other reputed company protected by federal, state or local law. Apply To This Job