Principal - QA API External Manufacturing Peptides

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Comprehensive benefits program

401(k) participation

Company bonus eligibility

Job summary

Initial Therapeutics, Inc. is looking for a skilled Quality Assurance professional to oversee API External Manufacturing operations. This role is critical for maintaining compliance with cGMP regulations and ensuring high-quality standards across third-party manufacturing partners.

Applicants should have a Bachelor's degree in a scientific discipline and at least 5 years of Quality Assurance experience in the pharmaceutical industry. The position is based in Indianapolis, Indiana and offers a competitive compensation package including potential bonuses and comprehensive benefits.

Qualifications

• Minimum 5 years experience in Quality Assurance in pharmaceutical or biopharmaceutical industry.
• Experience in auditing external manufacturing sites.
• Strong understanding of API manufacturing processes.

Responsibilities

• Lead and manage quality aspects of external API manufacturing sites.
• Conduct quality audits of external manufacturing sites.
• Review and approve quality-related documents.

Skills

Quality Assurance

cGMP regulations

Problem solving

Analytical skills

Quality management systems (e.g., Veeva)

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or Chemical Engineering

Job description

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.

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. This on-site role may be based at either the Indianapolis, IN or Durham, NC sites.

Job Summary:
This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners.

Job Responsibilities:

• Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control.
• Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards.
• Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods.
• Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement.
• Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers.
• Develop, implement, and maintain quality agreements with external manufacturing organizations.
• Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs).
• Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites.
• Mentor and provide technical guidance to junior QA associates.

Basic Requirements:

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering or related scientific discipline.
• Minimum 5 years experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply.
• Experience in cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
• Experience in auditing external manufacturing sites.
• Experience in quality management systems (e.g., Veeva).
• Willingness to travel domestically and internationally to external manufacturing sites as required.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Strong understanding of API manufacturing processes, analytical techniques, and quality control principles.
• Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences.
• Excellent problem-solving, analytical, and critical thinking skills.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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