Sr. Scientist - Quality Systems

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player seeks a dedicated Scientist to enhance their Quality Management System. This role emphasizes compliance with regulatory standards, ensuring the highest quality in pharmaceutical manufacturing. As part of a collaborative team, you will lead initiatives to improve quality processes, conduct training, and analyze data trends. If you are passionate about quality assurance and eager to make a significant impact in healthcare, this opportunity is perfect for you. Join a team that values innovation and strives for excellence in every aspect of their work.

Qualifications

• 3-5 years of experience in a pharmaceutical manufacturing environment is beneficial.
• Ability to investigate, collect data, and analyze trends for management reviews.

Responsibilities

• Maintain and improve the Quality Management System (QMS) for compliance.
• Support governance meetings and data analysis for management reviews.
• Develop and maintain local Quality SOPs and training tools.

Skills

Problem Solving Skills

Strong Communication Skills

Organizational Skills

Project Management Skills

Ability to Handle Multiple Tasks

Education

Bachelor's Degree in Science or Related Field

Tools

Veeva (QualityDocs, QMS)

SuccessFactors

SAP

Microsoft Office Suite

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.