Eli Lilly and Company
Sr Principal/Advisor - Business Quality Assurance- Analytical & QC Integrated Se
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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.Organization Overview:Eli Lilly and Company is dedicated to bringing innovation to patients and is growing its manufacturing operations significantly to meet the demand for our medicines.As a result, our Global Quality Analytical & QC Operations (AQCO) team is also growing.The Sr Principal – Business Quality Assurance (BQA) ensures laboratory activities conducted by AQCO areas or Contract Laboratories are carried out in accordance with Lilly Global quality standards and compliant with current Good Manufacturing Practice (cGMP). The Sr Principal– BQA will have quality assurance responsibilities and oversight for global computer systems and applications for all aspects of AQCO operations (e.g., observations, deviations, analytical investigations, change controls, equipment qualifications, computer systems validation, method validation, transfer protocols, summary reports, and data integrity initiatives).Additionally, the Sr Principal– BQA will be responsible for review and Quality approval of AQCO and Site documents supporting submissions to regulatory agencies and the new product and technical agendas, as needed.Detailed responsibilities:
Provide Business QA (BQA) oversight to AQCO Informatics and global computer systems/applications (LUNA, NuGenesis, e-Release, DIVA, etc.)Assure that computer systems are operating in compliance with regulations and Lilly Global quality system standardsAssure commitments made to regulatory agencies (e.g., FDA, EMA) regarding quality business processes are evaluated for impact on computer systems and any enhancements/changes are made accordinglyActively partner and collaborate with Global MQ Tech@Lilly teams to improve operational excellence of local and global business processesReview deviations for global computer systems/lab applicationsReview change controls for global computer systems/lab applicationsReview and approve validation artifacts, includingrequirements, Business Continuity Plan, and other documentation as requiredAssess risk and determine risk categorization for global computer systems/applicationsas well as assigning risk/priority for each requirement in collaboration with the Global System OwnerProvide consultation support during validation testing, including User Acceptance TestingReview and approve business standard operating proceduresReview and agree on scope for new releasesReview and agree on development or abandonment of system changesBasic Requirements:
BS or MS, in field of Chemistry, Biology or related field At least 10 years of experience in the pharmaceutical industry.Knowledge of analytical testing practices, cGMPs, quality systems, and other regulatory requirementsExtensive knowledge of quality documentation, data integrity, computer system validation, and control processesAdditional Skills/Preferences:
TrackWise proficiencyExperience/knowledge of laboratory activities from the whole product life cycle, i.e. development through commercialization and implementation in Quality Control laboratories.Understanding of IT system design, controls, and usageExperience in Quality Assurance in a pharmaceutical manufacturing environmentExpertise with laboratory informatics applications such as Empower, LIMS, and eLN.Demonstrate leadership, business acumen, and project management skills.Proficiency in planning and carrying out tasks with a great degree of independence and also as part of a team, with minimal supervisionStrong relationship and communication skills and an ability to influence team members, leadership, and cross-functional teams.Demonstrated ability to utilize and implement various tools, systems, and processes resulting in improved operational excellence of laboratory and business operations.Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.Demonstrated ability to interpret and apply solutions to different situations by understanding customer needs and applying strong problem-solving skills.
Additional Information:Ability to work 8-hour days – Monday through Friday, onsite, Indianapolis, LTC- NorthAbility to support processes outside of routine working hours, as neededAbility to travel approximately 10% of the timeLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLilly
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Provide Business QA (BQA) oversight to AQCO Informatics and global computer systems/applications (LUNA, NuGenesis, e-Release, DIVA, etc.)Assure that computer systems are operating in compliance with regulations and Lilly Global quality system standardsAssure commitments made to regulatory agencies (e.g., FDA, EMA) regarding quality business processes are evaluated for impact on computer systems and any enhancements/changes are made accordinglyActively partner and collaborate with Global MQ Tech@Lilly teams to improve operational excellence of local and global business processesReview deviations for global computer systems/lab applicationsReview change controls for global computer systems/lab applicationsReview and approve validation artifacts, includingrequirements, Business Continuity Plan, and other documentation as requiredAssess risk and determine risk categorization for global computer systems/applicationsas well as assigning risk/priority for each requirement in collaboration with the Global System OwnerProvide consultation support during validation testing, including User Acceptance TestingReview and approve business standard operating proceduresReview and agree on scope for new releasesReview and agree on development or abandonment of system changesBasic Requirements:
BS or MS, in field of Chemistry, Biology or related field At least 10 years of experience in the pharmaceutical industry.Knowledge of analytical testing practices, cGMPs, quality systems, and other regulatory requirementsExtensive knowledge of quality documentation, data integrity, computer system validation, and control processesAdditional Skills/Preferences:
TrackWise proficiencyExperience/knowledge of laboratory activities from the whole product life cycle, i.e. development through commercialization and implementation in Quality Control laboratories.Understanding of IT system design, controls, and usageExperience in Quality Assurance in a pharmaceutical manufacturing environmentExpertise with laboratory informatics applications such as Empower, LIMS, and eLN.Demonstrate leadership, business acumen, and project management skills.Proficiency in planning and carrying out tasks with a great degree of independence and also as part of a team, with minimal supervisionStrong relationship and communication skills and an ability to influence team members, leadership, and cross-functional teams.Demonstrated ability to utilize and implement various tools, systems, and processes resulting in improved operational excellence of laboratory and business operations.Demonstrated ability to communicate effectively to customers, business partners, and staff including good oral, written, and visual presentations.Demonstrated ability to interpret and apply solutions to different situations by understanding customer needs and applying strong problem-solving skills.
Additional Information:Ability to work 8-hour days – Monday through Friday, onsite, Indianapolis, LTC- NorthAbility to support processes outside of routine working hours, as neededAbility to travel approximately 10% of the timeLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLilly
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