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:
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
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.