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Lilly Associate Director - Quality Assurance - CT Packaging in Indianapolis, Indiana

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 35,000 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.

Organization Overview:

The Associate Director - Quality Assurance - CT Packaging provides leadership for a team of quality professionals that deliver quality and compliance oversight for the Clinical Trial Packaging and Collaboration Partner organizations.

Responsibilities:

Coach/mentor individuals with respect to career and personal development.

  • Oversee the performance management process and development plans for all direct reports, ensuring the plans are aligned with site, Quality, and individual objectives.

  • Actively seek and expand the team's knowledge of applicable technology, regulations, and best practices through training and new opportunities.

  • Provide an interface between upper management and associate level employees.

  • Maintain open team communication through one-on-one and team staff meetings.

  • Provide Quality interface between CT Packaging QA and Collaboration Partners.

  • Provide interface between CT Packaging QA and Business Partners.

  • Be involved in defining the strategic direction for CT Packaging QA.

  • Oversee operations of batch delivery and remove obstacles preventing release.

  • Assure systems and resources exist to provide oversight of the packaging processes.

Quality

  • Assure proper review and approval of documents in alignment with Quality guidance, Global Quality System (GQS), PR&D Quality System, and current Industry Practices.

  • Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations, specifically in regard to packaging processes and Quality systems.

  • Evaluate and assess impact and action plans of proposed changes to processes, equipment (if applicable), and regulatory commitments.

  • Approve deviations and evaluate the potential impact on product quality and patient safety. Ensure adequate investigation and documentation. Assure proper root cause identification and establishment of effective corrective action plans to prevent reoccurrence.

  • Assure adequate procedures are available to cover all activities related to cGMPs.

  • Continually evaluate, maintain, and improve processes within Quality and areas of support.

  • Support inspection readiness activities such as site self-assessments to ensure the site is constantly in a state of inspection readiness.

  • Work with Collaboration Partners to resolve and improve Quality issues.

  • Evaluate systems for Data Integrity gaps and improvements.

Regulatory and Company Requirements

  • Observe, promote, and comply with regulatory requirements and corporate standards related to quality, safety, security, and cGMPs.

  • Assure compliance with regulatory commitments.

  • Escalate notification to management of any violation or departure and assure the issue is being addressed.

  • Assess gaps between local and corporate standards and facilitate efforts to remediate gaps.

Basic Requirements:

  • Bachelors or higher degree in a scientific field such as physical, chemical or biological sciences, engineering, or pharmacy.

  • Minimum of 5 years of cGMP experience

  • Previous management experience.

Additional Skills/Preferences:

  • Thorough knowledge of cGMPs and Quality Systems with demonstrated technical competency.

  • Previous experience in Quality Assurance highly desirable.

  • Previous experience in PR&D or PR&D QA desirable.

  • Previous experience working with external manufacturing/packaging partners.

Additional Information:

• Travel: less than 10%

• Position location: Indianapolis, IN

• Position requires onsite work the majority of the week.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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