India Job Openings
Lilly
Associate Vice President/Vice President Global Medicines Quality Organization
Indianapolis
FULL TIME
October 8, 2024
The Associate VP / VP, Global Medicines Quality Organization (GMQO), is responsible for providing leadership to the design, maintenance and implementation of integrated global quality systems that support Research and Development (R&D) activities primarily in the areas of clinical development, patient safety, and regulatory affairs. The Associate VP / VP provides direction to the execution of quality systems, management of audit and inspection activities, and appropriate monitoring of the external environment to maintain sustainable compliance and drive continuous improvement. To achieve this, the Associate VP / VP works with functional business areas and drug/device development teams across R&D, and with supporting areas including Ethics and Compliance, Legal, and other components of the Global Quality organization.
Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.
Leadership/Supervision
-
Ensure a sustainable and technically capable organization is in place.
-
Enhance the capabilities of the organization through effective recruiting, training, coaching and development of GMQO personnel.
-
Ensure that the optimal organizational structure is in place for achieving objectives effectively and efficiently.
-
Enable desired behaviors throughout the organization through clear communication and respect for people.
-
Simplify and prioritize work to enable effective decision making.
-
Partner with leadership across functions to ensure a shared vision for quality and to strategically position quality to enable critical business strategies.
Quality Execution, Monitoring, and Continuous Improvement
-
Ensure the ongoing execution and monitoring of a global quality system that effectively supports Lilly-sponsored clinical development, patient safety, and regulatory activities conducted by Lilly and third parties.
-
Provide quality support through consistent application of global processes to portfolio, functions, business units, and affiliates.
-
Assure appropriate notification to management and resolution of quality related issues.
-
Ensure consistent inspection readiness. Establish processes for the management of internal and external audits and ensure any findings are addressed in a timely manner.
-
Provide quality leadership to the oversight and governance of third parties contributing to Lilly-sponsored clinical development, ensuring compliance, quality, and continuous improvement are achieved.
External Focus
-
Monitor external regulatory and industry direction for incorporation into the design and execution of R&D processes.
-
Actively engage with appropriate external organizations and agencies to influence the environment and anticipate changes.
Basic Qualifications/ Requirements:
-
Bachelor’s Degree in a science-related field
-
A minimum of 10 years of direct experience with clinical development, patient safety or regulatory affairs with demonstrated understanding and application of quality management systems
-
Broad functional expertise and experience in clinical development and quality roles
-
Knowledge of industry practices and applicable clinical development quality standards and regulations
-
Experience working with regulatory authorities and in managing regulatory inspections.
-
Ability to assess and manage risk in a highly regulated environment.
-
Ability to evaluate business needs and develop strategic plans that assure quality and/or drive quality improvement.
-
Experience working with external partners.
Additional Preferences:
-
Additional experience beyond clinical development specifically in patient safety and regulatory
-
Master of Science or Ph D preferred
-
Ability to collaborate with internal business partners and achieve results through them
-
Strong leadership and employee management skills
-
Strong teamwork and communication skills
Additional Information:
-
Infrequent travel required.
Lilly 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.
#We Are Lilly
New Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Delivery Tax Consultant II
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Tax Delivery Manager
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate Director - Assurance Data Analytics and Automation Strategy
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate - Scientific Communications
Indianapolis
FULL TIME
November 18, 2024
View Job DescriptionLooking for similar job?
Levi Strauss & Co.
Associate Analyst- Commercial Operations
Bengaluru
FULL TIME
September 6, 2024
View Job Description
Manipal Health Enterprises
Senior Associate - Nursing
Bengaluru
September 6, 2024
View Job Description
See What’s New: Lilly Job Opportunities
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job DescriptionNew Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Delivery Tax Consultant II
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Tax Delivery Manager
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate Director - Assurance Data Analytics and Automation Strategy
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate - Scientific Communications
Indianapolis
FULL TIME
November 18, 2024
View Job Description