Head of Quality Assurance – Pharma (Remote)

Euromed Pharma Us Inc; Raleigh (NC); On-site; USD 160,000 - 210,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

401(k) matching

Performance bonus

Competitive salary

Dental insurance

Training & development

Vision insurance

Wellness resources

Job summary

Euromed Pharma US Inc is seeking a driven Director of Quality US to lead quality assurance and drive a culture of compliance across the organization. You will own QMS processes, lead regulatory inspections, and oversee Responsible Person activities for wholesale distribution.

The role requires strong leadership, extensive regulatory knowledge, and hands-on experience with audits, CAPA, and DSCSA compliance.

Qualifications

• Bachelor's degree or higher in Pharmacy, Life Sciences, Chemistry, or related field.
• 7+ years of quality assurance experience in the pharmaceutical industry.
• Familiarity with FDA, DSCSA, State Boards of Pharmacy.
• Strong understanding of US, EU, UK and international regulatory frameworks.
• Auditing experience (internal and external) of suppliers, vendors, and contractors.
• Knowledge of ISO9001 QMS and Controlled Drug regulations (US DEA).

Responsibilities

• Quality Assurance & QMS Oversight: Maintain and develop the Quality Management System; own CAPA, Change Control, Deviations, Complaints, Document Control, Data Integrity, Recalls and Internal Audits.
• RP: Ensure compliance with FDA, cGDP, DSCSA, licenses; verify supplier/customer bona fides; oversee recalls and returns; approve training; validate storage and transport records.
• Oversee administrative duties for distribution including contracts, SOPs, and regulatory records; participate in senior decisions on quarantine/recall of medicines.
• Maintain inspection readiness; ensure compliance with Health & Safety, Pharmacovigilance, Falsified Medicines legislation; promote ethical practices; provide training and leadership.
• Perform delegated duties in absence of colleagues; assist with additional duties as required by management.

Skills

Leadership

Cross-functional Leadership

Regulatory knowledge

Communication

Training & mentorship

Quality assurance

Auditing

Team leadership

Education

Bachelor's degree in Pharmacy / Life Sciences

Tools

ISO 9001 QMS

DEA Regulations

DSCSA Compliance

GxP Knowledge

Job description

Euromed Pharma US Inc is seeking a driven Director of Quality US to lead quality assurance and drive a culture of compliance across the organization. You will own QMS processes, lead regulatory inspections, and oversee Responsible Person activities for wholesale distribution.

The role requires strong leadership, extensive regulatory knowledge, and hands-on experience with audits, CAPA, and DSCSA compliance.