Eli Lilly and Company
Sr Director - PR&D QA Analytical
This job is now closed
Job Description
- Req#: R-52282
Responsible for the management oversight of the QA units supporting Analytical Development across both SMDD and BR&D organizations (Development and GMP Laboratories), including the Corporate Reference Standards Operations and external laboratories.
Collaborates with PR&D and Global Quality Groups to qualify external collaboration partners, suppliers and/or partners to ensure compliance is met and maintained.
Ensure cGMP Compliance within Analytical Development through establishment and utilization of appropriate quality systems.
Lead improvement initiatives related to quality systems, implementation of new Quality Standards, and monitoring the effectiveness of the Quality System.
Ensures that QA review and/or approval occurs for GMP documents including but not limited to Qualification documents, Change Controls, Specifications, Stability Protocols, deviations/ OOS and OOT results, audit related documents in a timely fashion to support the overall portfolio as well as clinical trial needs.
Manages resourcing, audit plans for internal and external sites, and ensure sites remain qualified to execute their operations under cGMP.
Develop people in the organization through performance management, development plans, coaching, mentoring and challenging assignments.
Establishes and maintains appropriate QA functionality, sufficiently capable through a combination of education, experience and training to execute the roles and responsibilities for QA for supported areas.
Provides leadership in responding to and managing inspection requests, authors/approves responses/commitments made to address findings, and communicates/escalates issues when appropriate.
Minimum of a Bachelor's Degree in a science related field such as Chemistry, Biological Sciences or related Life Sciences or equivalent experience
At least 10 years of experience in the Pharmaceutical Industry in areas including Analytical, Quality Assurance/ Quality Control
Previous experience in leadership roles
Experience interacting with Regulatory agencies such as the FDA, EMA, ICH, OSHA and EPA.
Previous experience in Regulatory or MS&T
Prior work managing external partners
Ability to influence team interactions and lead initiatives
Demonstrated problem solving skills
Demonstrated solid judgment and initiative.
Ability to work under time pressure and exert good judgment in special situations
Must exhibit good teamwork, communication, and interpersonal skills.
Occasional travel may be required for collaboration partner oversight, training, conferences, etc. (up to 10%).
This position is onsite the majority of the time in Indianapolis, IN. This is not a remote 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 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:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Product Research and Development (PR&D) QA Analytical organization is part of the PR&D QA organization. PR&D QA provide the Quality oversight for the PR&D organization which includes Synthetic Molecule Drug Development (SMDD), Biologics Research & Development (BR&D) and clinical trial material supply. The PR&D QA Analytical organization provides quality oversight for the Analytical Development organization which includes SMDD and BR&D. BR&D provides oversight for the GMP analytical activities.
Responsibilities:The Sr Director of Quality Assurance – Analytical provides administrative and technical leadership within Product Research and Development (PR&D) Quality Assurance (QA), and collaborates with Analytical and Development business partners to ensure quality and compliance requirements are met. The Director brings a mind-set of continuous improvement to Lilly's internal operations and external partners. The individual participates on the local Quality Lead Teams and may also serve as a liaison for the other PR&D QA Sr Directors.
Basic Requirements:
Additional Skills/Preferences:
Additional Information: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 ( Lilly_Recruiting_Compliance@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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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About the company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries.