Director, Commercial Quality & eQMS (Remote)

Rx Group; United States; À distance; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Fully remote

Occasional in-person team time

Résumé du poste

Rx Group is seeking a senior quality leader to drive the migration to an enterprise eQMS and to build the commercial quality systems needed for launch. The role is hands-on with clear ownership, reporting to a senior quality leader and partnering with clinical, regulatory, CMC and commercial colleagues.

You will oversee migration to Veeva Vault, develop GMP/GCP compliant procedures, and ensure readiness for inspections as the company transitions from clinical development to commercial operations.

Qualifications

• Typically 10+ years in GxP quality and quality leadership.
• Hands-on experience implementing or migrating an eQMS, ideally Veeva Vault.
• Strong computer system validation knowledge, including SaaS systems and 21 CFR Part 11.
• Experience building quality processes from scratch through late-stage development and commercial launch.
• Working understanding of GCP and clinical team operations.
• Practical, collaborative approach with good risk judgement.
• Based in the US and authorized to work in the US without sponsorship.

Responsabilités

• Lead the migration to Veeva Vault, including requirements, configuration, validation and data migration.
• Build commercial quality processes, including product complaints, management review and oversight of annual product reviews from manufacturing partners.
• Write quality procedures that work for each team, including clinical (GCP) colleagues.
• Own document control, training, change control, CAPA and related processes.
• Keep the quality system risk-based and right-sized for a small company.
• Support inspection readiness and lead on quality systems during audits and inspections.

Connaissances

GxP quality leadership

Quality systems management

Risk-based quality

Outils

Veeva Vault

Description du poste

Rx Group is seeking a senior quality leader to drive the migration to an enterprise eQMS and to build the commercial quality systems needed for launch. The role is hands-on with clear ownership, reporting to a senior quality leader and partnering with clinical, regulatory, CMC and commercial colleagues.

You will oversee migration to Veeva Vault, develop GMP/GCP compliant procedures, and ensure readiness for inspections as the company transitions from clinical development to commercial operations.