Sr. Scientist - Quality Systems

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 63,000 - 141,000; Full time

Job summary

A leading company in healthcare is seeking a Scientist/Sr. Scientist/Principal Scientist to maintain and improve its Quality Management System. The role involves ensuring compliance with regulations, managing quality systems, and collaborating across teams. Ideal candidates will have a science degree and experience in pharmaceutical manufacturing, alongside strong communication and problem-solving skills.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Employee assistance program

Qualifications

• 3-5 years of experience in pharmaceutical manufacturing environment preferred.
• Relevant experience in Quality Assurance department in pharmaceutical industry preferred.

Responsibilities

• Maintain and support the Quality Management System (QMS).
• Collaborate across the business and manage data in electronic quality management system.
• Provide quality system expertise and support interpretation of regulations.

Skills

Problem solving

Communication

Organizational skills

Project management

Education

Bachelor’s degree in science or related field

Tools

Veeva

Microsoft Office

SAP

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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always

The Scientist / Sr. Scientist / Principal Scientist, Quality Systems role is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, and company requirements. This role will support Quality Systems and various activities with Quality oversight for GxP processes, ensuring compliance with GxP, regulatory, and business requirements. This includes supporting and/or facilitating, but not limited to, governance meetings, gathering data, and data analysis trending for quarterly management reviews. As an integral member of the Quality Systems team, this position maintains and continuously supports the improvement of all aspects of the Quality Management System. The Quality Systems Scientist champions quality principles, consistent document hierarchy (architecture) decisions, assignment and delivery of training curricula, and the integration of requirements into QMS documents to continuously improve the Lilly quality system.

Quality System Responsibilities

• Provide technical expertise in executing quality system objectives while assuring compliance with applicable regulations and Lilly standards.
• Collaborate across the business and maintain the systems and business processes to manage data in the electronic quality management system.
• Identify and document system issues, investigate data related discrepancies and troubleshoot issues encountered by end users, while working with other quality system team members, IT and global support personnel, when necessary, to resolve these issues.
• Collaborate with management to identify training needs and ensure appropriateness of training plans, creating and assigning curricula as required.
• Contribute to the training, education, guidance, and influencing of operational and support areas on quality system policy and practices.
• Evaluate and assess the effectiveness of training plans through feedback and performance metrics.
• Develop and maintain local Quality SOPs, training, and tools for managing and maintaining EQMS data and systems.
• Ensure technical review and approval for documents, including deviation/CAPA, change controls, procedures, etc.
• Cross train and provide back-up support for other roles under Quality Systems.
• Utilize and provide accounts on metric reports in the EQMS systems and provide data trending and metrics to management.
• Support the preparation, planning, logistics, and execution of self-inspections, mock inspections, and other inspection readiness activities.
• Provide quality system expertise to the organization, ensuring compliance by supporting interpretation of regulations and during planning and process/continuous improvement plans, projects and assisting in gap analysis and activities to implement improvements. At the Principal Scientist Level, this role may lead gap analysis activities and drive activities to implement improvements.
• Prepare and present Quality Management Reviews to assess the effectiveness of the Quality Systems; identify unfavorable trends and collaborate with stakeholders and functions to ensure their timely mitigation.
• Act as Meeting Manager for Change Review Board responsible for coordinating with business stakeholders to schedule topics, facilitate meetings, and collaborate with the meeting chair to ensure efficient meetings.
• Serve as Document Controller supporting document creation, revision, review, approval, and retirement workflows, ensuring accurate metadata in the electronic system.
• Fosters a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement
• Perform other duties as assigned

Minimum Qualification Requirements:

• Bachelor’s degree in science or related field.
• Experience in pharmaceutical manufacturing environment (3-5 years of experience beneficial).

Other Information/Additional Preferences:

• Knowledge in Veeva (QualityDocs, QMS), SuccessFactors, SAP is preferred.
• Strong communication and organizational skills.
• Problem solving skills.
• Proficiency in Microsoft Office suite applications (Excel, Word, PowerPoint)
• Ability to handle multiple tasks simultaneously while meeting deadlines
• Relevant experience in Quality Assurance department in pharmaceutical industry preferred
• Ability to investigate, collect data, and analyze trends for management reviews assigned for quality processes.
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Project management skills, experience in process improvement, and the ability to be solution focused on the design and implementation of quality and process improvements.
• Familiarity with GxP regulations.

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

$63,000 - $140,800

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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