What are the responsibilities and job description for the Sr. Director - Quality Assurance Packaging and Distribution position at BioSpace?
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
$151,500 - $222,200
Job Title: Sr. Director/Executive Director – Quality Assurance, Packaging and Distribution
Position Type: Full-Time
Location: Indianapolis, LTC-N
Job Level: M3
Job Function: Quality Assurance
Supervisor: Assoc. VP – Quality Assurance, PRD
Position Description: We are seeking a Sr. Director/Executive Director to provide management oversight and technical leadership to our Quality Assurance (QA) groups. This role involves collaborating with Product Research and Development (PR&D) to ensure quality and compliance requirements are met within the Clinical Supply and Delivery (CSD) groups. The successful candidate will oversee packaging and labeling of CT materials, supply planning, IWRS, sample management, and distribution according to current PRD Quality Standards and Good Manufacturing Practices (cGMP's). The Sr. Director will also participate on the local Quality Lead Teams and serve as a liaison for other PR&D QA Sr. Directors on the CSD Lead Team. This role requires a continuous improvement mindset to enhance internal operations and external partnerships.
Key Objectives/Deliverables
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
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Job Title: Sr. Director/Executive Director – Quality Assurance, Packaging and Distribution
Position Type: Full-Time
Location: Indianapolis, LTC-N
Job Level: M3
Job Function: Quality Assurance
Supervisor: Assoc. VP – Quality Assurance, PRD
Position Description: We are seeking a Sr. Director/Executive Director to provide management oversight and technical leadership to our Quality Assurance (QA) groups. This role involves collaborating with Product Research and Development (PR&D) to ensure quality and compliance requirements are met within the Clinical Supply and Delivery (CSD) groups. The successful candidate will oversee packaging and labeling of CT materials, supply planning, IWRS, sample management, and distribution according to current PRD Quality Standards and Good Manufacturing Practices (cGMP's). The Sr. Director will also participate on the local Quality Lead Teams and serve as a liaison for other PR&D QA Sr. Directors on the CSD Lead Team. This role requires a continuous improvement mindset to enhance internal operations and external partnerships.
Key Objectives/Deliverables
- Management oversight of QA units supporting CT Packaging, Labeling, Supply Planning, IWRS, Distribution, K401 Operations, CT-Win, Sample Management, and associated third parties.
- Collaboration with PR&D and Global Quality Groups to qualify CPs, suppliers, and partners to ensure compliance.
- Leading improvement initiatives and ensuring cGMP Compliance through appropriate quality systems.
- Supporting and advising business personnel on quality-related matters, including escalated issues such as deviations, complaints, and potential withdrawals.
- Ensuring timely QA review and/or approval of various GMP documents to support clinical trial delivery timelines.
- Overseeing department workload planning, performance planning, and regulatory compliance.
- Developing people in the organization through performance management, development plans, coaching, mentoring, and challenging assignments.
- Ensuring sites remain qualified to execute their operations under cGMPs.
- Providing overall support and logistics for internal and external audits.
- Bachelor’s degree in Chemistry, Biology, Engineering, or a Scientific Field.
- Demonstrated strong leadership skills.
- Ability to work and accomplish results independently.
- Problem-solving skills and broad knowledge of packaging, quality systems, and global quality standards.
- Understanding of regulatory agencies' requirements such as FDA, EMEA, ICH, OSHA, and EPA, particularly in the area of cGMPs.
- Solid judgment and initiative.
- Ability to organize and prioritize multiple tasks and problem-solve effectively.
- Ability to work under time pressure and exert good judgment in special situations.
- Good teamwork, communication, and interpersonal skills.
- Ability to influence team interactions and lead initiatives.
- Ability to work simultaneously with several subjects between interactions and distractions.
- 8-10yrs Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable.
- Occasional travel may be required for collaboration partner oversight, training, conferences, etc.
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
Salary : $151,500 - $222,200
