BioSpace, Inc.
BioSpace, Inc. is hiring: PR&D Associate Director CT Packaging and Distribution
BioSpace, Inc., Indianapolis, IN, United States, 46262
Job Details
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
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.
The QA Associate Director will provide administrative and technical leadership to a group of individuals that provide Quality oversight for Zone 1 (North and South America) distribution of Clinical Trial (CT) material. This includes oversight and qualification of Third-Party Distribution hubs and depots, daily pick/pack/ship operations, oversight of cold chain logistics projects, and the Temperature Excursion Investigation Centre. This also includes providing Quality oversight for the daily operation of the North American Clinical Trial Distribution facility (K401). The QA Associate Director will also provide administrative and technical leadership to a group of individuals that provide Quality oversight for CT labels and sample management.
Basic Requirements:
*this role requires the individual to be onsite three days per week
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.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
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.
The QA Associate Director will provide administrative and technical leadership to a group of individuals that provide Quality oversight for Zone 1 (North and South America) distribution of Clinical Trial (CT) material. This includes oversight and qualification of Third-Party Distribution hubs and depots, daily pick/pack/ship operations, oversight of cold chain logistics projects, and the Temperature Excursion Investigation Centre. This also includes providing Quality oversight for the daily operation of the North American Clinical Trial Distribution facility (K401). The QA Associate Director will also provide administrative and technical leadership to a group of individuals that provide Quality oversight for CT labels and sample management.
Basic Requirements:
- Bachelor's degree or greater in chemistry, Biology, Pharmacy, Engineering, or other physical science.
- 5+ years of industry-related experience.
- 10 - 15% including international travel.
- Experience effectively managing a scientific or quality organization.
- Detailed knowledge of regulatory expectations related to Quality.
- Proven track record of driving continuous improvement.
- Excellent collaboration and communication skills.
- Previous experience in commercial, PR&D, or PR&D QA desirable.
- Detailed scientific knowledge and experience in labelling and/or distribution desirable.
- Experience working with Collaboration Partners (CPs) or other external partners desirable.
- Provide administrative and technical leadership to the QA group supporting Distribution, Licensing, Temperature Excursion, Labelling, and Sample Management.
- Ensure appropriate quality systems are implemented, and the roles and responsibilities of the quality unit are carried out for all CT Distribution activities in Zone 1 and K401.
- Provide Quality oversight and ensure roles and responsibilities of the quality unit are carried out for all Site Temperature Excursion (TEIC).
- Ensure roles and responsibilities of the quality unit are carried out and all applicable licenses are in place to enable K401 operation.
- Support through effective quality oversight of CPs/Service Providers (SPs) that provide services for CT distribution in Zone 1 (e.g., carriers, shipping containers, warehousing, receipt, sampling, destruction, shipping, etc.) and labelling services.
- Approve GMP documents as required by appropriate procedures.
- Escalate quality decisions to the appropriate level for final resolution.
- Ensure appropriate and complete deviation and change controls are completed, impact determined, and corrective measures are identified and implemented effectively.
- Drive transformation and continuous improvements within the quality processes for oversight of areas of responsibilities.
- Ensure quality deliverables within areas of responsibilities are completed effectively and on-time to support the PR&D pipeline.
*this role requires the individual to be onsite three days per week
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.
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly