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.

Position Description:

The Advisor - Quality Assurance, provides quality guidance, oversight and risk management required for the manufacture and supply of Active Pharmaceutical Ingredients (APIs), overseeing all quality activities at External Manufacturing organizations (EMs). This role has an emphasis on API EM’s portfolio of large molecule activities (including monoclonal antibodies, microbial products, gene therapy and bioconjugate products). Additional responsibilities of the role include ensuring development and continuous improvement of quality-related business processes to support the API EM site’s commercialization mission, enhancing standardization where appropriate and incorporating learnings and best practices. Lastly, this role provides coaching and mentorship to members of the QA team and other functions within the API EM team.

Key Objectives/Deliverables:

• Ability to support key portfolio assets in the API EM large molecule portfolio, participating in and driving resolution of key issues, including influencing senior management at key partners.

• Guide and proactively improve site risk management practices and commercialization business processes to deliver commercial supply and commercialization assets.

• Act as a coach/mentor for the current quality assurance team, providing guidance and problem-solving skills to address key issues.

• Participate in regulatory inspection preparations and provide on-site support during inspections.

• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.

• Assist other functions in the interpretation of regulatory and global requirements.

• Participate on the Technical Review Board; authorization to approve as equivalent to Quality Assurance Associate Director for deviations, complaints and changes.

• Serves as a Subject Matter Expert on SOPs and other quality documents.

• Participate/lead projects to improve quality system alignment and productivity.

• Lead and/or participate in global and local projects with global impact.

Basic Requirements:

• BS in a science-related field such as Pharmacy, Chemistry Biological Sciences, Engineering, or related Life Sciences.

• 5+ years previous quality assurance experience.

• Thorough technical understanding of quality systems and CGMP regulatory requirements.

• Previous experience with CGMP manufacturing of large molecules (monoclonal antibodies, microbial products, gene therapy and/or bioconjugated products).

• Knowledge of pharmaceutical manufacturing operations.

• Demonstrated coaching and mentoring skills.

• Experience in root cause analysis and creation of effective CAPA plans.

• Demonstrated strong written and verbal communications skills.

• Strong attention to detail.

• Excellent interpersonal skills and networking skills.

• Ability to organize and prioritize multiple tasks.

• Ability to influence diverse groups and manage contract relationships.

Additional Preferences:

• Advanced degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, Engineering, or related Life Sciences strongly preferred

• 3+ years experience in another manufacturing functional area (TSMS, process engineering, QC).

• Thorough technical understanding of quality systems and regulatory requirements

• Previous experience influencing senior leadership

Other Information:

• Must complete training requirements for Advisor – QA – API EM

• Role is positioned in Kinsale, Ireland supporting External Manufacturing activities with some travel to Contract Manufacturer sites (Approximately 15 percent Travel)

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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