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Lilly is currently constructing an advanced manufacturing facility for production of APIs (small molecule and peptide) located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide for current and future products, including new modalities.
Main Purpose And Objectives
The Senior Director – Quality Control is part of the Senior Leadership Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC Labs throughout the start-up, implementation, and day-to-day operations of LP1.
The Sr. Dir. – QC 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.
Key Responsibilities
Provide technical leadership, performance management, training and development of staff
Maintain a safe work environment
Ensure GMP compliance
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.
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
Ensure adequate oversight and technical excellence for investigations and complaints
Collaborate with site team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio
Provide oversight for technical projects to improve process control, capacity, yield, and quality
Ensure adequate technical representation and engagement within the 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
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
Minimum Requirements
Bachelor’s Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
10+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
Additional Preferences
Ability to influence and lead diverse groups
Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
Strong analytical and quantitative problem-solving skills
Experience with Empower software
Experience with LIMS implementation and use within a manufacturing environment
Experience with statistical analysis of data
Technical leadership, administrative and organizational skills
Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
Demonstrated Project Management skills and ability to coordinate complex projects
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
Ability to build relationships with internal and external customers and partners
Enthusiasm for changes, team spirit and flexibility
Demonstrated ability to learn & apply technical/scientific knowledge
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 for further assistance.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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