Quality Assurance - External Manufacturing Compliance - Documentation Management

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly in Indianapolis invites applications for an EM Quality Assurance QA Representative. This role oversees the global quality standards for documentation and data integrity, coordinating with Drug Product External Manufacturing and API teams to ensure GMP compliance and audit readiness.

The position focuses on SOP maintenance, training design, and contributing to cross-functional quality initiatives, with occasional travel and a day shift.

Qualifications

• Bachelor's Degree in a science related field.
• 2+ years of hands-on GMP-regulated pharmaceutical experience with document control or quality systems.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Provide oversight of departmental document management systems and data integrity initiatives.
• Serve as liaison between L&D and EM for documentation and training.
• Lead implementation of quality document initiatives and drive process improvements.

Skills

Teamwork

Independent work

Computer systems

Education

Bachelor's Degree in science-related field

Tools

Trackwise

QDocs

ServiceNow

SuccessFactors

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 (<20%).

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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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