Sr. Director - QA Early Phase (I) Clinical Trial

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$151,500 - $222,200

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Main Purpose and Objectives of Position

The Sr. Director QA Early Phase CT is responsible for leading and managing all aspects of quality assurance for early phase clinical trials across Lilly’s portfolio (including but not limited to synthetic small, biological large molecules, and conjugates). This role ensures that clinical trial material is prepared in compliance with regulatory requirements and company standards. The Sr. Director QA collaborates with cross-functional teams and external partners to ensure the compliant delivery of investigational material for early phase clinical trials.

Key Responsibilities

• Develop and implement quality assurance strategies and plans for early phase clinical trials.

• Oversee the production of materials to be used for conduct of clinical trials to ensure compliance with regulatory requirements GMP (e.g., FDA, EMA) and Good Clinical Practice (GCP) guidelines.

• Collaborate with Technical Teams, Regulatory Affairs, and other departments to resolve quality issues and ensure continuous improvement.

• Provide leadership and direction to the Early Phase QA team, including hiring, training, development, and performance management.

• Develop and maintain QA standards and procedures related to early phase clinical trials.

• Monitor and report on QA metrics and key performance indicators (KPIs).

• Ensure appropriate documentation and record-keeping for all QA activities.

• Stay current with industry trends and regulatory changes to ensure compliance and best practices.

• Represent the company in interactions with regulatory agencies.

• Lead evaluation of new modalities to incorporate appropriate regulatory expectations

• Support mergers and acquisitions including material in licenses as they relate to early phase clinical trials

Basic Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.

• 10+ years of experience in quality assurance within the pharmaceutical or biotechnology industry, with a focus on early phase clinical trials.

• In-depth knowledge of FDA, EMA, and other relevant regulatory requirements.

Additional Preferences

• Ability to interpret/apply phase-appropriate GMP standards

• Proven track record of successfully leading QA teams and managing complex projects.

• Strong communication skills, both written and oral.

• Ability to shift priorities rapidly to meet tight deadlines.

• Attention to detail and accuracy of work.

• Strong problem-solving and decision-making skills.

Additional Information

• Travel: 10-15%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmat