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. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs

Role Summary

We are seeking an experienced Senior Director, Head of Quality Assurance to craft a strategy and tactical execution to oversee quality aspects of the organization from Quality Assurance (QA) to Quality Control (QC). The leader will implement processes, systems, and other mitigation strategies to minimize risk, track key QA metrics, and oversee audit preparedness. The (Senior) Director will be responsible for building and leading a strategic, phase-appropriate QA function that ensures the rigor, regulatory compliance, and timely delivery of high-quality drug products. This role will serve as a key primary GCP and GMP QA subject matter expert and point of contact for all GCP/GMP/GLP related matters and issues. As part of a highly collaborative team, the QA leader will partner with development operations, CMC, supply chain, regulatory, PV, and clinical development functions as part of aligning QA needs with business and development strategy. This leader will be both big picture and hands on, with ability to manage day to day quality oversight while contributing to overall strategy though technical leadership.

Role Scope

• Leads the creation and implementation of QA programs, policies, and procedures across to ensure that clinical and non-clinical studies align with relevant regulatory requirements and industry standards
• Represent QA on project teams and inform stakeholders of GCP/GMP/GLP matters and related risk management
• Expand QMS in order to refine QA processes and operations in order to prepare for audits; partner to determine audit strategy, frequency, site selection, and oversee tracking and reporting
• Responsible for quality assurance oversight of clinical and non-clinical study documentation, including materials submitted to regulatory authorities
• Ensure adherence to global regulatory guidelines (ICH, FDA, EMA) and proactively prepare for regulatory submissions and inspections, including contributions to INDs and NDAs.
• Oversee data integrity, method lifecycle documentation, and timely delivery of stability, release, and comparability reports to support regulatory filings and internal milestones
• Maintain continuous improvement of quality processes and procedures
• Establish and manage Quality and Compliance Training program for GxP staff, and companywide initiatives. 
• Qualify and manage relationships with contract research and manufacturing organizations. This includes the assurance of compliance and quality of operations performed by these organizations, as well as regulatory inspection support.
• Serves as the primary QA liaison to business stakeholders, representing QA in strategic discussions and cross-functional forums, while facilitating communication between QA and other departments to support key corporate objectives and pipeline milestones
• Defines QA strategy for assigned areas in alignment with business priorities; navigates complex challenges, ensures timely escalation, and drives issue resolution

• Advanced scientific degree (PhD, MSc) in Biology, Pharmacology or related discipline
• 12+ years of experience in the biopharmaceutical industry with significant expertise in small molecule GCP/GMP oversight; at least 5 years of experience in a leadership role
• Proven expertise in GxP standards (GLP, GCP, GMP, GVP), the drug development lifecycle, and relevant global regulatory frameworks and requirements
• Deep working knowledge of analytical platforms used in small molecule development and commercial release.
• Direct experience in managing Health Authority GCP Inspections. Experience supporting BIMO inspections is preferred.
• Extensive knowledge and understanding of ICH E6 GCP Guideline, FDA and EU Requirements
• Hands-on experience in authoring regulatory documentation and participating in FDA or global Health Authority interactions
• Strong business acumen and ability to operate effectively in a lean, fast-paced biotech environment
• Experience supporting programs from IND through commercialization
• Experience and understanding of Data Integrity requirements and electronic systems used in Clinical trials
• Track record of fostering high-trust relationships across internal and external stakeholders
• A “can do” attitude and ability to operate in a fast-paced startup environment

The expected salary range for this position is $230k - $280k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer