Lilly
Senior Director, Quality
Lilly, Pleasant Prairie, Wisconsin, United States, 53158
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:Lilly is expanding capability at a new state of the art Parenteral Facility in Kenosha County, Wisconsin. This is an exciting opportunity to help build upon an existing foundation to expand reach to the patients we serve. The Quality Assurance (QA) organization ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of the Quality Management System. QA actively participates in the commercialization and supply of medicines that help people live longer, healthier, more active lives. The Senior Director, Quality Assurance, is primarily responsible for overseeing the execution of the Quality Management System. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. He/she will also provide quality support for achieving key business objectives.
Responsibilities:
The Senior Director, Quality Assurance, is responsible for providing technical understanding and communication regarding the execution of the quality management system.
He/she effectively influences the leadership on strategic direction and tactical implementation of the quality system.
The individual in this role establishes the site’s quality objectives, priorities, and roadmap.
He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements.
The individual in this role has supervisory responsibilities providing both administrative and technical leadership to the site.
He/she oversees daily work and provides direction on key priorities as needed.
This individual ensures that the products are fit for their intended use and comply with US and international regulatory requirements.
The Sr. Director, Quality Assurance, ensures all required quality agreements are in place and maintained.
He/she leads and responds to regulatory agency inspections and inquiries.
Basic Requirements:
Bachelor of Science degree or equivalent in a scientific field (e.g., chemistry, microbiology, engineering)
Minimum of 10 years in the pharmaceutical industry
Minimum of 10 years of leadership experience, preferably in Quality Assurance
Additional Information:
Flex hours possible
Must have ability to travel (approximately 10-20%)
Position requires onsite presence; this is not a remote worker role
Eli Lilly and Company is 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 for further assistance.
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.
#WeAreLilly
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Organization Overview:Lilly is expanding capability at a new state of the art Parenteral Facility in Kenosha County, Wisconsin. This is an exciting opportunity to help build upon an existing foundation to expand reach to the patients we serve. The Quality Assurance (QA) organization ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of the Quality Management System. QA actively participates in the commercialization and supply of medicines that help people live longer, healthier, more active lives. The Senior Director, Quality Assurance, is primarily responsible for overseeing the execution of the Quality Management System. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. He/she will also provide quality support for achieving key business objectives.
Responsibilities:
The Senior Director, Quality Assurance, is responsible for providing technical understanding and communication regarding the execution of the quality management system.
He/she effectively influences the leadership on strategic direction and tactical implementation of the quality system.
The individual in this role establishes the site’s quality objectives, priorities, and roadmap.
He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements.
The individual in this role has supervisory responsibilities providing both administrative and technical leadership to the site.
He/she oversees daily work and provides direction on key priorities as needed.
This individual ensures that the products are fit for their intended use and comply with US and international regulatory requirements.
The Sr. Director, Quality Assurance, ensures all required quality agreements are in place and maintained.
He/she leads and responds to regulatory agency inspections and inquiries.
Basic Requirements:
Bachelor of Science degree or equivalent in a scientific field (e.g., chemistry, microbiology, engineering)
Minimum of 10 years in the pharmaceutical industry
Minimum of 10 years of leadership experience, preferably in Quality Assurance
Additional Information:
Flex hours possible
Must have ability to travel (approximately 10-20%)
Position requires onsite presence; this is not a remote worker role
Eli Lilly and Company is 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 for further assistance.
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.
#WeAreLilly
#J-18808-Ljbffr