Sr Director – Global Quality Systems – Advanced Therapy Medicinal Products (ATMP)

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.

The Sr Director Global Quality Systems (GQS)- Advanced Therapy Medicinal Products (ATMP) role will support the GQS organization, business functions, and sites involved in Cell and Gene Modalities.

• Lead the development and maintenance of Global Quality Standards with a focus on Cell and Gene therapy standards and Global Quality Practices.
• Serve as the Global Subject Matter Expert (SME) on Cell and Gene Therapy Quality requirements and Standards, advising senior management, functions, and sites for key decisions concerning ATMP.
• Lead the assessment for compliance with ATMP regulations and the development, implementation, and maintenance of Gene Therapy standards and industry practices.
• Actively collaborate with development, commercialization, and manufacturing organizations in the understanding, application, and implementation of Gene Therapy standards.
• Develop and maintain global education and training on Gene therapy standards as well as developing implementation tools to promote consistent business processes.
• Periodically perform a maturity assessment for the cell and gene therapy system.
• Develop and support communities of practice associated with Gene therapy business topics, including the development and monitoring of metrics to monitor performance and identify and escalate trends for global management reviews.
• Actively collaborate with site local process owners in the compliance with standards and inspection readiness and support activities.
• Determine and implement global actions from site inspection observations and trends.
• Mentor / coach local process owners.
• As a subject matter expert, directly interact with health regulatory authorities during inspections and draft responses to observations as needed.
• Lead and / or support the assessment, development, and implementation of complex and critical global projects in support of continual Global Quality System improvements.
• Closely partner with Global Quality Compliance (GQC) External Monitoring process by being continually aware of current industry trends and regulations updating GQS standards and practices as required.
• Actively engage in external organizations and industry organizations to advocate / influence quality related policies and regulatory requirements related to ATMP.
• Network with global and other applicable networks to understand best practices and share knowledge for continuous improvement.
• Participate in tactical and strategic business planning within the GQC and Networks.

Basic Requirements :

• Minimum Bachelor's degree in a science, engineering, pharmaceutical-related field of study
• Minimum of 18 years in biotechnology, pharmaceutical or medical research. Strong preference given to candidates that a portion of this experience is directly related to the cell or gene therapy space.
• Experience with cGMP and quality systems, including EU and US Cell and Gene (ATMP) guidance and regulations.

Additional Skills / Preferences :

• Proficiency in planning and carry out tasks with a great degree of independence and as part of a team, with minimal supervision.
• Demonstrated ability to interpret and apply standards in complex situations, understanding customer needs, and applying problem solving skills.
• Experience in leading teams to accomplish objectives.
• Excellent interpersonal, written and oral communication skills.
• Strong technical aptitude and ability to train and mentor others.
• Demonstrated technical writing skills.
• Continuing education / master’s degree or higher in science, engineering, or ATMP related field.
• Previous experience directly supporting a pharmaceutical operation; preference for support of cell or gene therapy.
• Previous regulatory inspection readiness and inspection execution experience.
• Previous facility or area start up experience, including equipment and process validation support.
• CQM or CQE certification from the American Society for Quality (ASQ)
• Project management experience

Additional Information :

• Ability to periodically adjust work hours to support needs of global sites.
• Ability to travel 10-20% for support of new and existing sites, industry training and conferences and other meetings.

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