Director of Quality US

Job Description

Job Description

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.