Director, Quality Management Systems

Rx Group; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Fully remote

Occasional in-person team time

Job summary

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.

Responsibilities

• 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.

Skills

GxP quality leadership

Quality systems management

Risk-based quality

Tools

Veeva Vault

Job description

Our client is a publicly listed, late-stage pharmaceutical company developing an oral small molecule treatment. Having completed pivotal development, the company is preparing for its first commercial launch. It is a lean, fully remote team based across the US, working with outsourced manufacturing and clinical partners.

About the role

This is a new role to lead the company's quality management system as it moves from clinical development to commercial. You will lead the move to a new eQMS and build the processes a commercial company needs. It is a hands-on build role with real ownership, reporting to a senior quality leader and working closely with clinical, regulatory, CMC and commercial colleagues.

What you’ll do

• 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, practical and right-sized for a small company.
• Support inspection readiness and lead on quality systems during audits and inspections.

What you’ll bring

• Typically 10+ years in GxP quality, with significant quality systems 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, ideally through late-stage development and commercial launch.
• A working understanding of GCP and how clinical teams operate.
• A practical, collaborative approach and good judgement on risk.
• Based in the US and authorized to work in the US without sponsorship.

What’s on offer

• The chance to shape a commercial quality system at a key point in the company’s growth.
• A senior, visible role in a small team, working with an experienced quality leader.
• Fully remote working, with occasional in-person team time.