Director, Product Quality (Biotech)

TL;DR

Director, Product Quality (Biotech): Providing strategic direction for product manufacture and distribution with an accent on GMP/GDP compliance and QMS optimization. Focus on reducing operational risk, managing CMO partnerships, and ensuring commercial readiness for mental health treatments.

Location: Hybrid in New York City or remote on the East Coast, USA

Salary: $180,000 - $240,000 USD

Company

A biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, specifically developing synthetic psilocybin treatments.

What you will do

• Lead enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce risk and support growth.
• Provide subject matter expertise in GMP and GDP, ensuring consistent application across internal and external operations.
• Act as the primary Quality point of contact for Contract Manufacturing Organisations (CMOs).
• Manage all quality aspects of commercial readiness and dual supply chains for clinical and commercial products.
• Lead, develop, and coach the Product Quality team to build strong organizational capability.

Requirements

• Must be based in the US (specifically the East Coast).
• Must have existing employment rights in the US (no sponsorship provided).
• At least 12 years of pharmaceutical industry experience, with 7 years at a managerial level.
• Scientific or engineering degree and a postgraduate qualification in Quality Management.
• Proven understanding of GMP, GCP, Pharmacovigilance, and Quality Management requirements.
• Experience applying continuous improvement techniques such as RCA, CAPA, Lean, and Six Sigma.

Culture & Benefits

• Base salary supplemented by discretionary bonuses and equity.
• Comprehensive benefits package provided to all employees.
• Commitment to workplace wellbeing and reasonable accommodations during the interview process.
• Inclusive environment with a strong commitment to diversity and equality.