Authorized Quality Representative

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.

Position Brand Description:
The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored, and maintained. The Authorized Quality Representative (AQR) in IPM is responsible for final batch release of Semi-Finished and supports and assists the plant quality leadership in managing key technical, quality, and compliance issues. They also provide guidance, coaching, and advice to the plant process teams and flow teams (cross-functional) on quality and compliance matters and mentor the operations quality organization to continue to develop capabilities related to quality assurance and compliance as well as parenteral manufacturing. As needed, they participate in and support regulatory inspections and internal audits.

Key Objectives / Deliverables:
* Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
* Performs final batch disposition of semi-finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
* Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
* Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
* Effectively review / approve GMP documents to ensure quality attributes are met (i.e., deviations, procedures, protocols, specifications, and change controls).
* Participates in process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
* Ensure regular presence in operational areas to monitor GMP programs and quality systems.
* Review / approve RtQs and updates to regulatory submissions for commercial products, as appropriate.
* Approve regulatory specification updates in the LIMS.
* Approve the country list in SAP for the semi-finished item codes.
* Review / approve changes to core labelling of commercial products related to the drug product properties.
* Review APRs, ensuring the quality of the data analysis and of the conclusions.
* As needed, participates in review boards and approves (level permitting) deviations, change controls, and complaints.

Coaching / Mentoring:
* Lead, Mentor, and Coach Site personnel on quality matters associated with the Batch and the Batch Disposition process.
* Provide technical leadership to key quality matters. Provide direction and coaching regarding major and/or significant deviations and investigations.
* Coach and mentor quality operations and other functions supporting parenteral manufacturing operations in topics related to quality and GMP compliance, operational excellence, technical documentation, issue resolution, and process monitoring.
* Support on-boarding and on-going development of technical capability of quality personnel (e.g., Comprehensive Quality Review representatives, QA process team members, etc.)
* Provide regular communication with QA operations staff and Process Teams to resolve issues or provide advice on product related issues.
* Share routine feedback with Operations and Process Teams based on learning from batch reviews to share learning from batch issues and prevent recurrence, explain the "why" behind batch issues, and to recognize and reinforce areas where Operations is performing well.

Cross-functional, Network, and Customer Interactions:
* Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.
* Interact with regulators or other outside stakeholders on quality / compliance issues or in support of internal and external agency audits.

Basic Qualifications:

Bachelor's degree in a scientific field (e.g., chemistry, biology, engineering, pharmacy, or similar) with relevant years of experience in the pharmaceutical industry. Preferably 5+ years' experience directly supporting pharmaceutical manufacturing or quality, with experience in parenteral pharmaceutical products.

Minimum Requirements:
* Demonstrated relevant experience in a GMP facility.
* Critical thinking.
* Proficiency with computer systems.
* Ability to work independently and with minimal supervision.
* Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
* Strong dialog and crucial conversation skills, with the ability to consider differing viewpoints respectfully and with an open mind.
* Attention to detail.
* Coaching skills.

Additional Preferences:
* Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function.
* Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.
* Strategic thinking and ability to balance short term needs with long term business evolution.
* Proficiency with local computer systems including Veeva, TrackWise, PMX, and SAP

Other Information:
* Second shift (3:00PM-11:30PM) Tuesday to Saturday, possible off-shift support.
* Tasks require entering manufacturing areas which require wearing appropriate PPE.
* This position is tech ladder approved.

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 ( ) 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.

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