Director of Quality & Compliance - Pharma

Euromed Pharma Us Inc; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

401(k) matching

Bonus based on performance

Competitive salary

Dental insurance

Training & development

Vision insurance

Wellness resources

Flexible work from home options

Job summary

Euromed Pharma US Inc is seeking a driven Director of Quality US to lead QA initiatives and shape the quality culture of a growing pharmaceutical organization. This senior role oversees regulatory compliance, inspections, and a robust QMS.

You will manage CAPA, deviations, audits, and supplier oversight while partnering with supply chain, logistics, and commercial teams to ensure product quality and regulatory readiness. Strong leadership and cross‑functional collaboration are essential.

Qualifications

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, or related field.
• 7+ years of quality assurance experience in pharmaceutical industry.
• Familiarity with FDA, DSCSA, State Boards of Pharmacy.
• Strong understanding of US/EU/UK and international regulatory frameworks (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.
• Detail‑oriented, decisive, and commitment to continuous improvement.

Responsibilities

• Maintain and develop the Quality Management System to support third‑party logistics in compliance with regulations.
• Own and manage key QMS processes: CAPA, Change Control, Deviations, Complaints, Document Control, Data Integrity, Recalls, Internal Audits.
• Lead Management Reviews and promote continuous improvement.
• Align quality processes with warehousing, logistics, and supply chain activities.
• Provide input into strategic compliance initiatives and process efficiency.
• Serve as primary contact for regulatory inspections, audits, and agency communications.
• Represent the company during regulatory inspections and customer audits.
• RP duties: ensure FDA/cGDP compliance for wholesale distribution and DSCSA obligations; oversee recalls and training programs.

Skills

Leadership

Regulatory knowledge

Communication

Cross-functional collaboration

Quality assurance

Strategic thinking

Education

Pharmacy

Life Sciences

Chemistry

Job description

Euromed Pharma US Inc is seeking a driven Director of Quality US to lead QA initiatives and shape the quality culture of a growing pharmaceutical organization. This senior role oversees regulatory compliance, inspections, and a robust QMS.

You will manage CAPA, deviations, audits, and supplier oversight while partnering with supply chain, logistics, and commercial teams to ensure product quality and regulatory readiness. Strong leadership and cross‑functional collaboration are essential.