Remote Senior Director, Project Quality & Compliance

Flourish Research; Washington (District of Columbia); Teletrabalho; USD 180 000 - 260 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Dental insurance

Vision insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Disability insurance

Generous PTO and holidays

Resumo da oferta

Flourish Research is seeking a Senior Director of Project Quality to champion the companywide QMS, drive quality improvements, and ensure regulatory compliance across all sites. The role leads the Project Quality team, partners with Process Quality, and supports sponsor audits and inspections.

Remote work is supported with up to 30% travel; the ideal candidate has 8+ years in clinical quality and a master’s degree, plus deep GCP knowledge and leadership abilities.

Qualificações

• Master's degree or equivalent.
• 8+ years in quality and compliance in clinical research.
• Expert knowledge of GCP and regulatory submissions.

Responsabilidades

• Build, implement, and manage a companywide QMS.
• Lead quality reviews, CAPA, and risk management across sites.
• Oversee eQMS implementation and site audits.
• Provide guidance on SOP harmonization and regulatory compliance.
• Report quality metrics and coordinate with sponsors, IRBs, and FDA.

Conhecimentos

Quality management

GxP knowledge

Regulatory compliance

Leadership

CAPA & RCA

Risk assessment

FDA/IRB liaison

Formação académica

Master's degree

Ferramentas

eQMS

Office365

Descrição da oferta de emprego

Flourish Research is seeking a Senior Director of Project Quality to champion the companywide QMS, drive quality improvements, and ensure regulatory compliance across all sites. The role leads the Project Quality team, partners with Process Quality, and supports sponsor audits and inspections.

Remote work is supported with up to 30% travel; the ideal candidate has 8+ years in clinical quality and a master’s degree, plus deep GCP knowledge and leadership abilities.