Lilly
Sr Principal/Advisor - Business Quality Assurance- Analytical & QC Integrated Se
Lilly, 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 standards
Assure 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 accordingly
Actively partner and collaborate with Global MQ Tech@Lilly teams to improve operational excellence of local and global business processes
Review deviations for global computer systems/lab applications
Review change controls for global computer systems/lab applications
Review and approve validation artifacts, including requirements, Business Continuity Plan, and other documentation as required
Assess risk and determine risk categorization for global computer systems/applications as well as assigning risk/priority for each requirement in collaboration with the Global System Owner
Provide consultation support during validation testing, including User Acceptance Testing
Review and approve business standard operating procedures
Review and agree on scope for new releases
Review and agree on development or abandonment of system changes
Basic 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 requirements
Extensive knowledge of quality documentation, data integrity, computer system validation, and control processes
Additional Skills/Preferences:
TrackWise proficiency
Experience/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 usage
Experience in Quality Assurance in a pharmaceutical manufacturing environment
Expertise 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 supervision
Strong 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- North
Ability to support processes outside of routine working hours, as needed
Ability to travel approximately 10% of the time
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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 standards
Assure 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 accordingly
Actively partner and collaborate with Global MQ Tech@Lilly teams to improve operational excellence of local and global business processes
Review deviations for global computer systems/lab applications
Review change controls for global computer systems/lab applications
Review and approve validation artifacts, including requirements, Business Continuity Plan, and other documentation as required
Assess risk and determine risk categorization for global computer systems/applications as well as assigning risk/priority for each requirement in collaboration with the Global System Owner
Provide consultation support during validation testing, including User Acceptance Testing
Review and approve business standard operating procedures
Review and agree on scope for new releases
Review and agree on development or abandonment of system changes
Basic 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 requirements
Extensive knowledge of quality documentation, data integrity, computer system validation, and control processes
Additional Skills/Preferences:
TrackWise proficiency
Experience/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 usage
Experience in Quality Assurance in a pharmaceutical manufacturing environment
Expertise 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 supervision
Strong 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- North
Ability to support processes outside of routine working hours, as needed
Ability to travel approximately 10% of the time
#J-18808-Ljbffr