Eli Lilly

Quality Assurance - External Manufacturing Compliance - Documentation Management

Eli Lilly • $65K — $169K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a related science field such as Engineering, Pharmacy, Chemistry, or Biological Sciences.
  • 2+ years of experience in a GMP-regulated pharmaceutical environment, focusing on document control or quality systems.
  • Authorization to work in the U.S. on a full-time basis without sponsorship.
  • Proficient in computer system applications relevant to document management.
  • Strong written, verbal, and interpersonal communication skills.

Responsibilities

  • Serve as the primary contact for documentation management across various manufacturing domains.
  • Liaise between the Learning & Development central team and EM for aligned documentation and training.
  • Lead initiatives in global QualityDocs forums to foster collaboration.
  • Promote continuous improvement and automation in EM documentation practices.
  • Provide oversight of SOPs and guidance documents related to document management and data integrity.
  • Design and deliver training on document management systems.
  • Manage the maintenance of the EM document management system in accordance with GMP expectations.

Benefits

  • Participation in a company-sponsored 401(k) and pension plan.
  • Vacation, medical, dental, vision, and prescription drug benefits.
  • Flexible benefits including healthcare and dependent daycare accounts.
  • Life insurance and death benefits offered.
  • Access to well-being benefits like an employee assistance program and fitness initiatives.
Full Job Description
External Manufacturing (EM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination. EM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Representative will provide oversight into departmental document management systems and data integrity initiatives to ensure compliance with the Global Quality Standards, cGMPS and with other departmental documentation.

Key Objectives/Deliverables
  • Serve as the primary point of contact for documentation management across Drug Product External Manufacturing (DPEM), Dry External Manufacturing (DryEM), and APIEM, ensuring seamless coordination and compliance.
  • Serve as the primary liaison between the Learning & Development (L&D) central team and EM, ensuring effective communication, collaboration, and alignment of documentation and training initiatives.
  • Represent the organization in global QualityDocs forums, leading the implementation of key initiatives and fostering cross-functional collaboration.
  • Champion a culture of continuous improvement and automation within EM documentation practices, proactively identifying and driving process enhancements.
  • Act as the Business Area Representative for EM's Veeva Quality Documents control groups.
  • Provides oversight and maintains document management and data integrity related SOPs and guidance documents.
  • Design and deliver training sessions on document management systems, empowering team members to maintain up-to-date expertise and operational excellence.
  • Ensure that the EM document management system is maintained efficiently and aligned with GMP expectations.
  • Ensure system audit trail reviews are completed for electronic document management systems (EDMS)
  • Support overdue document monitoring for EDMS.
  • Escalate quality or compliance issues through line management, if necessary.
  • Provide support in the preparation (audit readiness) and execution (audit logistics) of internal audits.
  • Support outsourcing activities from a documentation and training set up activities.
  • Participate in the creation and revision of standard operating procedures if necessary.
  • Manage and coordinate GMP Library activities being the SME contact.


Basic Requirements
  • Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
  • 2+ years of hands-on experience in a GMP-regulated pharmaceutical environment, with direct involvement in document control, quality systems, or a related compliance function.
  • 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 Skills/ Preferences
  • Proficiency of computer system applications.
  • Previous experience in the pharmaceutical industry.
  • Teamwork and interpersonal skills exhibited across functional areas: technical, leadership, administrative.
  • Ability to work independently.
  • Experience in Lilly electronic quality systems preferred (Trackwise, QDocs, ServiceNow, SuccessFactors).
  • Strong written, verbal, and interpersonal communication skills.
  • Ability to seamlessly balance multiple projects and tasks.
  • Strong attention to detail.
  • Improvement mindset.


Additional Information
  • Shift is days, but off-hours may be necessary to support operations.
  • Some travel is possible (

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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