Sr. Principal Associate - Quality AQR

Eli Lilly and Company•Indianapolis, IN

About The Position

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. The Sr. Principal Associate QA Authorized Quality Representative - AQR is responsible for final disposition of Finished drug products. This role provides guidance to the site in managing key technical, quality, and compliance issues related to the batch release during the product life cycle and annual review process. The AQRs serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards. Provide guidance, coaching, and advice to the related 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 device assembly and wet / dry packaging. Participate, as needed, in regulatory inspections as subject matter expert for batch release topics and provide coaching to subject matter experts. Key Objectives: Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

Requirements

Bachelor Degree in chemistry, science, engineering and pharmacy
Previous experience directly supporting pharmaceutical manufacturing or quality, with experience in pharmaceutical products
Ability to make technical decisions, provide guidance to the site and lead others.
Proficiency with applicable computer systems.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

Preferred 5+ years’ experience directly supporting pharmaceutical manufacturing or quality, with experience in pharmaceutical products.
Proven ability to work independently or as part of a team to resolve an issue.
Proficiency with SAP, MES (PMX), Darwin, and TrackWise, Veeva
Technical Writing and Communication Skills
Demonstrated strong oral and written communication skills.
Demonstrated interpersonal skills and the ability to work as a team.
Root cause analysis / troubleshooting skills.
Demonstrated attention to detail and ability to maintain quality systems.

Responsibilities

Quality Systems Management Own or serve as a subject matter expert of change controls, deviations, process validation activities, or other quality items related to the batch release and annual product review processes for vials, devices, and dry products.
Perform final batch disposition of semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging products, including commercial, clinical, and non-commercial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
Accountable to lead and serve as a liaison for the evaluation and completion of shipment under quarantine request.
Qualifies quality representatives in the batch release process for vials, sub-assembly, final assembly, and dry packaging.
Contribute to the execution of APRs
Provide 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., Non- conformances, procedures, protocols, specifications, and change controls).
Participate in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or other areas designated in the site.
Ensure regular presence in operational areas to monitor GMP programs, quality systems, and strengthen quality culture.
Can be identified as power user of systems such as SAP and EWM
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.
Provide technical leadership to key quality matters related to major and/or significant deviations and investigations.
Coach and mentor quality operations and other functions supporting in topics related to batch disposition review, annual product holistic review, quality and GMP compliance, operational excellence, technical documentation, issue resolution, and process monitoring.

Benefits

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).

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