Director of Quality US

Benefits: 401(k) Health insurance Paid time off 401(k) matching Bonus based on performance Competitive salary Dental insurance Training & development Vision insurance Wellness resources About the Role: Euromed Pharma US Inc is looking for a driven and experienced Director of Quality US to lead and champion quality assurance initiatives. This is a high-impact leadership role where you'll shape the quality culture of a growing pharmaceutical organization. If you're passionate about compliance & regulatory, excellence, and making a difference in the pharma industry, we want to hear from you. Key Responsibilities: 1. Quality Assurance & QMS Oversight Maintain and develop the company’s Quality Management System to support third party logistics activities in compliance with all state, federal and international regulations as applicable Own and manage key QMS processes, including CAPA, Change Control, Deviations, Complaints, Document Control, Data Integrity, Recalls and Internal Audits Lead Management Reviews and promote a culture of continuous improvement Ensure alignment between quality processes and operational functions, including warehousing, logistics, and commercial supply chain activities Provide input into strategic business initiatives, driving process efficiency and compliance Serve as the primary point of contact for regulatory inspections, audits, and agency communications Represent the company during regulatory inspections (Authority and customer audits 2. Responsible Person (RP) Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person Maintain compliance with the Drug Supply Chain Security Act (DSCSA), including serialization, verification, and transaction documentation Maintain and approve supplier and customer bona fides; ensure all third-party licenses are verified and current Oversee recall, returns, complaints, and falsified product investigations Approve training programs and verify competence of all staff involved in distribution activities Authorize return to saleable stock decisions and oversee product storage, temperature excursions, and transport records Approve contracts and SOPs related to distribution and outsourced activities Ensure records for the minimum period required by the law Participate in senior-level decisions relating to quarantine, disposal, or recall of medicines Fulfil the obligations required for importation of medicinal products Ensure products are only imported from authorized sites and meet all local quality requirements before release Verify that products imported under the WDA(H) are fully compliant Work closely with supply chain partners and import/export authorities to ensure compliance at all touchpoints Represent the company during FDA, customer, and state inspections Additional Responsiblities Maintain inspection readiness at all times across facilities and systems Ensure full compliance with internal policies, including Health & Safety, Pharmacovigilance, Falsified Medicines legislation and corporate governance Safeguard company reputation by promoting ethical, compliant, and customer focused business practices Provide training, mentorship, and leadership to quality and operational staff Perform delegated duties in the absence of colleagues where appropriate Other duties which may be reasonably required from time to time by company managers, including delegated duties during the absence of colleague. Requirements: Bachelor's degree or higher in Pharmacy, Life Sciences, Chemistry, or a related field 7+ years of quality assurance experience in the pharmaceutical industry Familiarity with federal and state regulatory frameworks (e.g. FDA, DSCSA, State Boards of Pharmacy) Preferred: completion of certified training in Good Distribution Practice Strong understanding of US, EU, UK and international regulatory frameworks (e.g. FDA, EMA, MHRA) Auditing experience (internal and external) of suppliers, vendors, and contractors Familiarity with ISO9001 QMS and Controlled Drug regulations (US DEA) Knowledge of US Customs and Border Protection requirements Knowledge of COSHH and hazardous goods transportation Excellent interpersonal, written and verbal communication skills Strong leadership, communication, and cross-functional collaboration skills Team oriented with leadership, training, and delegation capabilities Customer focused, innovative, and process-improvement minded Detail-oriented, decisive, and committed to a culture of continuous improvement About Us: Euromed Pharma US Inc is part of the 60-year strong Petrone Group, dedicated to delivering high-quality, innovative healthcare and pharmaceutical solutions globally. Our team is driven by a shared commitment to patient safety, regulatory excellence, and scientific integrity. We offer a collaborative and forward-thinking work environment where talented professionals can grow and make a meaningful impact in the pharmaceutical industry. Flexible work from home options available.