Associate Director- Quality Control

1 month ago

Indianapolis, United States Lilly Full time

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 (

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