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Role Overview:
- Build and scale an integrated QMS in a growing pharma/biotech environment preparing for commercialization.
- Report to the VP of Global Quality and establish risk-based quality processes supporting GMP, GCP, and broader GxP activities.
Key Responsibilities:
- Lead quality governance, computerized system oversight, and audit readiness.
- Manage deviations, CAPA, change control, document control, training, risk management, and CSV/CSA.
- Partner with stakeholders to embed quality standards while maintaining business agility.
What We Offer:
- Base salary $220,000-$235,000 USD annually, plus target bonus and equity compensation.
- Medical, dental, vision, 401(k), ESPP, life insurance, and disability coverage.
- Fully remote within the continental US, with up to 10% travel.
Requirements:
- Bachelor's degree in a scientific discipline and 8+ years of GxP Quality experience.
- Proven leadership in quality systems and cross-functional collaboration.
- Expertise in CSV, data integrity, and regulatory inspection support.
Partner Company
This pharmaceutical and biotechnology company is preparing for commercialization of an innovative treatment. It is a growing organization focused on building scalable quality systems, fostering a culture of quality ownership, continuous improvement, and regulatory compliance.