Senior Director, Head of Quality Assurance - Remote

Overview

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being.

In Short

• Seeking an experienced Senior Director, Head of Quality Assurance.
• Oversee quality aspects from QA to QC.
• Implement processes and systems to minimize risk.
• Ensure regulatory compliance and timely delivery of drug products.
• Lead development of QA programs, policies, and procedures.
• Manage quality assurance oversight of study documentation.
• Ensure adherence to global regulatory guidelines.
• Establish and manage training programs for GxP staff.
• Qualify and manage relationships with contract organizations.
• Define QA strategy in alignment with business priorities.

Requirements

• Advanced scientific degree (PhD, MSc) in Biology, Pharmacology or related discipline.
• 12+ years of experience in the biopharmaceutical industry.
• Expertise in GCP/GMP oversight and drug development lifecycle.
• Knowledge of ICH E6 GCP Guideline and FDA/EU Requirements.
• Experience in managing Health Authority GCP Inspections.
• Hands-on experience in authoring regulatory documentation.
• Strong business acumen in a fast-paced biotech environment.
• Track record of fostering high-trust relationships.
• Ability to operate effectively in a startup environment.

Benefits

• Competitive salary range of $230k - $280k.
• Discretionary annual bonus based on performance.
• Opportunity to work in a collaborative team environment.
• Contribute to meaningful work in cancer therapeutics.
• Equal opportunity employer with a focus on diversity.