Senior Director Quality Control

Role Summary

Senior Director – Quality Control responsible for administrative and technical leadership in the development, performance, and maintenance of the QC Labs during start-up, implementation, and day-to-day operations at the Lilly Lebanon API site. Leads staff, ensures GMP compliance, and drives technical agenda and quality objectives within the site and network.

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

Qualifications

• Minimum: Bachelor‚Äôs Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
• Minimum: 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

Additional Requirements

• Ability to travel (approximately 10-20%)
• Onsite position