Qualified Person (QP), Quality Assurance & Batch Release

About This Role

At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our mission drives us to discover and bring life-changing medicines to those who need them most. We are committed to improving the understanding and management of disease, while also giving back to our communities through philanthropy and volunteerism. We approach our work with the utmost dedication, always putting people first. We are seeking a highly determined and experienced Qualified Person (QP) to join our esteemed Quality Assurance team.

This critical role is pivotal in upholding the highest standards of pharmaceutical quality and patient safety. As a Qualified Person, you will be entrusted with the vital responsibility of certifying the release of medicinal products, ensuring strict adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and all relevant regulatory requirements. You will play a central role in maintaining the integrity of our quality systems and contributing directly to our global commitment to delivering safe and effective medicines. This position offers a unique opportunity to make a significant impact within a dynamic and innovative environment, contributing to a legacy of scientific excellence and patient focus.

Key Responsibilities

• Certify batches of medicinal products for release, confirming full compliance with marketing authorizations, GMP, and other applicable national and international regulations, thereby ensuring product quality and patient safety.
• Provide expert guidance and oversight on all aspects of the Quality Management System (QMS), including active participation in its development, maintenance, and continuous improvement.
• Review and approve critical quality documentation, such as Standard Operating Procedures (SOPs), specifications, manufacturing instructions, and validation protocols.
• Lead or significantly contribute to the investigation and resolution of deviations, non-conformances, out-of-specification results, and complaints, ensuring thorough root cause analysis and the implementation of effective Corrective and Preventive Actions (CAPAs).
• Evaluate and approve change controls impacting product quality, manufacturing processes, analytical methods, and quality systems, ensuring regulatory compliance and product integrity are maintained.
• Act as a key contact and subject matter expert during internal audits, external audits, and regulatory inspections, providing comprehensive support and addressing findings effectively.
• Participate in the preparation and review of Product Quality Reviews (PQRs) to monitor product performance, identify trends, and drive continuous improvement initiatives.
• Contribute to the qualification and ongoing oversight of suppliers of critical raw materials, excipients, packaging materials, and contract manufacturers/laboratories.
• Promote and embed a robust quality culture across the organization through training, mentorship, and proactive engagement with cross-functional teams.
• Stay current with evolving national and international pharmaceutical regulations, guidelines, and industry best practices to ensure ongoing compliance and strategic foresight.
• Exercise independent judgment and decision-making on critical quality issues, always prioritizing patient safety and product quality.

Requirements & Qualifications

• A degree in Pharmacy, Medicine, Chemistry, Pharmaceutical Chemistry & Technology, Biology, or another relevant scientific discipline that fulfills the academic requirements for a Qualified Person as per EU Directive 2001/83/EC (and national transpositions).
• Proven eligibility and/or certification as a Qualified Person in accordance with relevant European pharmaceutical directives.
• Minimum of 5-7 years of progressive experience in Quality Assurance or pharmaceutical manufacturing operations within a GMP-regulated environment.
• Demonstrated in-depth knowledge and practical application of EU Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant GxP regulations and international guidelines.
• Strong understanding of pharmaceutical regulatory frameworks and the ability to interpret and apply complex regulatory requirements to operational activities.
• Excellent communication skills, both written and verbal, in English. Proficiency in additional languages relevant to the operational site may be an advantage.
• A proven track record of making sound, independent decisions under pressure, with a clear focus on product quality and patient safety.

Skills & Competencies

• Exceptional critical decision-making abilities, particularly concerning product quality and patient safety.
• Superior analytical and problem-solving skills to effectively address complex quality issues and identify robust solutions.
• Outstanding interpersonal, verbal, and written communication skills, capable of influencing and collaborating effectively across all organizational levels and with external stakeholders.
• Demonstrated leadership qualities with a strong commitment to ethical conduct and integrity, fostering a proactive quality culture.
• Meticulous attention to detail and a steadfast commitment to accuracy in all documentation and processes.
• Proven capability in comprehensive risk assessment, mitigation, and management within a pharmaceutical context.
• Ability to work effectively both independently and as part of diverse, cross-functional teams, driving consensus and achieving shared objectives.

What We Offer

Joining Eli Lilly means becoming part of a global team dedicated to pioneering scientific advancements and improving lives. We offer a stimulating work environment where your expertise as a Qualified Person will be highly valued and your contributions will directly impact patient outcomes. We are committed to fostering a culture of continuous learning, professional development, and mutual respect.

• A highly competitive salary package reflective of your experience and the critical nature of this role.
• Comprehensive health, dental, and vision insurance plans, ensuring your well-being and that of your family.
• Robust retirement savings programs and other financial wellness benefits.
• Significant opportunities for professional growth, continuous learning, and career advancement within a leading global pharmaceutical company.
• A dynamic and inclusive work environment that values diversity and encourages innovation.
• Meaningful work that directly contributes to bringing life-changing medicines to patients worldwide.
• Commitment to work-life balance and employee well-being initiatives.

How to Apply

If you are a determined and highly qualified individual passionate about maintaining the highest standards of quality and patient safety, and you are ready to contribute your expertise to a world-class pharmaceutical company, we encourage you to apply. Please submit your detailed resume and a compelling cover letter outlining your relevant experience, qualifications, and your vision for this pivotal role through our careers portal. We look forward to reviewing your application and exploring how your skills align with our mission to make life better for people around the world.