Qualified Person (QP) – Pharmaceutical Quality Assurance & Compliance

About This Role

At Eli Lilly and Company, we are driven by a profound purpose: to unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our commitment extends beyond developing life-changing medicines; it encompasses improving the understanding and management of disease, and actively giving back to our communities through philanthropy and volunteerism. We are a company where every employee gives their best effort, and crucially, where we put people first – our patients, our communities, and our dedicated team members. We are currently seeking a highly determined and experienced Qualified Person (QP) to join our dynamic team, contributing directly to our mission by ensuring the highest standards of pharmaceutical quality and regulatory compliance.

This pivotal role offers an exceptional opportunity to safeguard the quality and integrity of our pharmaceutical products, directly impacting patient safety and trust. The Qualified Person is a critical figure within the European pharmaceutical framework, responsible for certifying that each batch of medicine has been manufactured and checked in compliance with the marketing authorization and Good Manufacturing Practice (GMP) requirements. You will be instrumental in upholding Lilly’s unwavering commitment to quality, working within a collaborative and innovative environment that values scientific rigor, ethical practice, and continuous improvement. This position is ideal for a seasoned professional passionate about quality assurance, regulatory excellence, and making a tangible difference in global health.

Key Responsibilities

• Certify and release batches of medicinal products for sale or export, ensuring full compliance with the relevant Marketing Authorisation (MA), EU/local GMP regulations, and company quality standards.
• Provide expert guidance and oversight on all aspects of Good Manufacturing Practice (GMP) within the manufacturing and quality control operations.
• Review and approve critical quality documents, including Batch Records, Deviations, Change Controls, OOS investigations, CAPAs, and Product Quality Reviews (PQRs).
• Act as a key interface during regulatory inspections by national and international health authorities, providing clear and accurate information regarding quality systems and batch release processes.
• Contribute to the development, implementation, and maintenance of the Pharmaceutical Quality System (PQS), ensuring its effectiveness and continuous improvement.
• Participate in the qualification and auditing of suppliers and contract manufacturers, ensuring their adherence to Lilly's quality requirements and regulatory standards.
• Provide training and mentorship to colleagues on GMP principles and quality assurance best practices, fostering a strong quality culture across the organization.
• Oversee and approve validation activities for processes, equipment, and analytical methods relevant to product quality.
• Collaborate cross-functionally with manufacturing, quality control, regulatory affairs, and supply chain teams to resolve quality issues and facilitate efficient product flow.
• Stay abreast of evolving national and international GMP guidelines, regulations, and industry best practices, implementing necessary updates to internal procedures.

Requirements & Qualifications

• Eligibility to act as a Qualified Person (QP) as defined by EU Directive 2001/83/EC and 2001/20/EC, or equivalent local regulations, evidenced by relevant education and practical experience.
• A university degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology, or an equivalent scientific discipline recognized for QP eligibility.
• Extensive practical experience (typically 5+ years) in a pharmaceutical manufacturing or quality assurance environment, with a significant portion of this experience gained in a QP-eligible capacity.
• Profound knowledge of EU GMP guidelines, national pharmaceutical regulations, and international standards (e.g., ICH guidelines).
• Demonstrated experience in batch review, certification, and release processes for a variety of dosage forms.
• Strong understanding of Quality Management Systems (QMS) principles and their practical application.
• Excellent analytical, problem-solving, and decision-making skills with a meticulous attention to detail.
• Proven ability to communicate complex technical and regulatory information effectively to diverse audiences, both verbally and in writing.
• Strong leadership capabilities and the ability to influence without direct authority, fostering a culture of quality.
• Proficiency in English; additional language skills relevant to the location may be advantageous.

Skills & Competencies

• GMP and Regulatory Compliance Expertise
• Pharmaceutical Quality Assurance
• Batch Release & Certification
• Quality Management System (QMS) Oversight
• Critical Thinking & Problem Solving
• Decision Making & Accountability
• Effective Communication & Stakeholder Management

What We Offer

Joining Eli Lilly means becoming part of a company that truly values its people and their contributions to global health. We offer a stimulating and supportive work environment where innovation thrives, and professional growth is actively encouraged. As a Qualified Person at Lilly, you will have the opportunity to work with cutting-edge science and technology, collaborate with a global network of experts, and directly impact the lives of millions. We believe in rewarding our employees for their dedication and hard work.

• Competitive salary package, commensurate with experience and qualifications (Salary Range: -).
• Comprehensive health, dental, and vision insurance plans.
• Generous retirement savings programs with company contributions.
• Paid time off, including vacation, sick leave, and holidays.
• Opportunities for continuous professional development, training, and career advancement.
• Employee assistance programs and wellness initiatives to support work-life balance.
• A culture of diversity, inclusion, and belonging, where every voice is valued.
• The chance to contribute to meaningful work that improves health outcomes worldwide.

How to Apply

If you are a determined and highly qualified professional ready to take on a critical role in ensuring pharmaceutical quality and compliance, we encourage you to apply. Please submit your detailed resume and a cover letter outlining your experience and how you meet the requirements for this position. Join Eli Lilly and Company and help us continue our journey of uniting caring with discovery to make life better for people around the world.