BioSpace, Inc.
Associate Director- Quality Control
BioSpace, Inc., Lebanon, Indiana, United States, 46052
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.
The Associate Director - Quality Control is responsible for managing the activities of Quality Control personnel. The Assoc. Director Quality Control must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
Responsibilities Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. Performance management and development of staff. Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio. Ensure adequate oversight and technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas. Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites. Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization. Basic Qualifications:
Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field. 5+ of experience in Quality Control in a pharmaceutical manufacturing environment. Additional Preferences:
Responsible for maintaining a safe work environment Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues within the site and function Experience in statistics Technical leadership, administrative and organizational skills Builds relationships with internal and external customers and partners Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & apply technical/scientific knowledge Additional Information:
Minimal travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations
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.
#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.
The Associate Director - Quality Control is responsible for managing the activities of Quality Control personnel. The Assoc. Director Quality Control must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
Responsibilities Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc. Performance management and development of staff. Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio. Ensure adequate oversight and technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas. Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites. Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization. Basic Qualifications:
Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field. 5+ of experience in Quality Control in a pharmaceutical manufacturing environment. Additional Preferences:
Responsible for maintaining a safe work environment Ability to influence and lead diverse groups Influences complex regulatory, business, or technical issues within the site and function Experience in statistics Technical leadership, administrative and organizational skills Builds relationships with internal and external customers and partners Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Demonstrated Project Management skills and ability to coordinate complex projects Strong analytical and quantitative problem-solving skills Ability to communicate and influence effectively across functional groups and stakeholders Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Demonstrated ability to learn & apply technical/scientific knowledge Additional Information:
Minimal travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations
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.
#WeAreLilly