Sr. Manager - QA Stat Sort

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 Quality Assurance Statistical Sorting group assures patients worldwide of safe and
efficacious drug products, through effective quality oversight of Indianapolis Parenteral product inspection and statistical sorting program.

The Sr. Manager for QA Stat Sort team is responsible for managing the activities of Stat Sort personnel supporting Indy Parenteral Operations, with respect to managing the team's daily workload, performance evaluation, issue resolution, training, and personal development of employees. The Sr. Manager is essential for tracking department metrics to ensure productivity and alignment with departmental/site goals. The Sr. Manager is also responsible for individual contributor activities that may include: Process Owner, SOP/Training Owner, Technical expertise within Stat Sort, as well as process improvements.

Responsibilities:

Team leadership and personnel development:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Support the plant business plan and influence plant agenda to ensure reliable supply of quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readiness
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities
• Develop individuals and team to ensure continuous professional development
• Develop, lead, and support the site Safety, Quality and Compliance initiatives and culture.

Quality and Compliance oversight:

• Exhibit critical business decision making taking into consideration quality, compliance and business aspects, escalate critical quality issues, when appropriate, on a timely manner and proposing decisions into the escalation forum (e.g Flow Team)
• Ensure regular presence in stat sort areas to monitor GMP programs and quality systems.
• Participate and when needed to support regulatory inspections
• Ability to effectively review and/or approve (or reject) technical and quality documents to ensure quality attributes are met (i.e. Non-Conformances, procedures, technical studies, validation protocols, change controls, and engineering documents) and provide support in the absence of a Associate Director.
• Ensure adequate quality oversight for inspection activities and areas of responsibility
• Serve as Process Owner, SOP/Training Owner, Technical expert within Stat Sort and visual inspection/defect classification, as well as identify and drive process improvements.
• Ability to triage non-conformances that occur within the quality organization.
• Support Operations and investigations related to appropriate classification of defects

Basic Requirements:

• BSc in STEM discipline

Additional Skills/Preferences:

• Strong self-management and organizational skills, ability to prioritize, problem solve, mentor and coaching.
• Self-motivated, lead the way for ensuring a fair and equitable work environment
• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Experience in Production, QC, QA, Technical Services, Engineering or Regulatory is desirable.
• Previous experience with Lilly non-conformance and change control process
• Experience as mentor or trainer
• Parenteral visual inspection experience

Additional Information:

• Overtime may be required.
• May be required to respond to calls or be present offshift to resolve operational issues.
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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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).