Lilly Associate Manager Medicines Quality Organization (MQO) in Bengaluru, India
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.
This role is responsible for the design, implementation and execution of an integrated quality system to support LCCI’s evolving business model. This role is responsible for clinical development quality assurance, quality risk assessment and mitigation, continuous quality improvement, and inspection readiness. The purpose of the role is to be a quality advocate for the Clinical Data Management (CDM) and/or Statistics business units. For CDM, this requires an in depth understanding of data standards, data collection & design, data flow management, data quality, data validation, data review, central coding, data technology, dataset delivery, adjudication coordination, archiving and decommissioning. For Statistics, this requires an in depth understanding on establishing a reporting database and analyzing clinical trial data. The Quality Associate Manager works with management and the quality team to implement a strategy to strengthen quality of medical research by integrating quality into business processes.
Functional and Technical Expertise
Knowledge and experience in clinical development, development quality and/or related areas.
In-depth knowledge on end to end Clinical Data Management activities from study set up through database lock or in-depth knowledge on statistics activities.
Supports the Safety and Efficacy Quality System (SEQS) implementation and education of the business. Participates in SEQS procedure development and in Change Control as appropriate
Functions as the initial point of consultation for the business on SEQS related question
Responsible for providing input and feedback on quality standards and expectations
Consultants on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Informs and interprets changes in local, regional and global regulations
Provides guidance and consultation to the business to enable execution of external and internal regulations on a local, regional and global level to , ensure compliance and inspection readiness
Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans and regional and/or affiliate quality plans based on identified signal/risks/gaps
Defines, executes and documents quality self-assessments/self-inspections throughout the clinical development process and discusses output with business partners
Discusses output of quality self-assessments with business partners, provide recommendations on corrections and CAPA and monitor through to resolution
Supports and educates the business in developing robust CAPA, deviation management, root cause investigation, audit response management and inspection response management
Reports issues through Notification to Management (NTM) as appropriate
Participates in the development and implementation of the quality strategy for the Portfolio and Medical Affairs
Conducts process reviews based on quality data and trends. Shares results with the business
Inspection Readiness and Inspection Management
Leads pre-inspection preparation activities in collaboration with business partners
Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management
Actively supports site and sponsor inspections
Responsible for inspection response management and tracking through resolution
Coordinates audit responses including Trackwise system documentation
Functions as an expert in corrective and preventative actions (CAPA) management
Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections
Quality Decision Making
Uses risk based approach for effective communication to influence business decisions
Provides feedback to the business on the benefits and risks associated with an issue and/or business solution
Influence Quality Direction
Collaborates with other quality groups as appropriate and develops a quality network
Collaborates with compliance as appropriate and develops a working partnership
Shares key learning to drive simplification and replicate best practices
Actively participates in team and supported business area meetings
Acts as a point of contact and partner with compliance officer/Data privacy steward as appropriate
Consults on deviation management and root cause analysis
Utilizes quality experience to support change management and business transformation in the delivery of the portfolio
Support business in resolution of issues
Supports business in the escalation of issues including the escalation to leadership
Anticipates broader impact of an issue
Quality Technical Leadership
- Initiates, drives and coordinates quality improvement initiatives. Shares key learning's and drives quality into the business
Supports the implementation of harmonization of best practices, process improvements and provides feedback on effectiveness of implementation, challenges and best practice
Supports local, regional and global medical teams working on key projects
Minimum Qualification Requirements:
Bachelor’s Degree in a science, technology or medically-related field or equivalent relevant work experience
A minimum of 2 years experience in clinical development, development quality and/or related areas. In-depth knowledge on end to end clinical data management activities from study set up through database lock/ In-depth knowledge on statistics activities
Global perspective and working across functional and geographical boundaries
Knowledge of GxP regulations, guidelines and standards
Demonstrated understanding of quality principles, including policies, procedures and processes
Demonstrated ability to identify and prioritize quality issues.
Knowledge of the relevant regulatory framework
Ability to influence, negotiate and project manage
Ability to work effectively at all level of the organization
Effective organization/self-management skills
Excellent problem solving skills and initiative
Proficient written and spoken English language skills
Effective verbal communication
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 ( LillyRecruitingCompliance@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 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!