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.
Description of Role/Position
The Sr. Manager QC Support provides leadership to the Limerick QCL Support team, recruits and develops team members, and ensures delivery across QC support functions including equipment, training, sample management, compliance, audit readiness and eSystems. The position also has a business management, site management and team management role (consistent with Senior Manager roles across site).
Key Responsibilities
People Management:
• Provide leadership, direction and oversight of the QC Support team to meet customer goals such as operational readiness, compliance, audit support, equipment availability, and digital system reliability. • Establish yearly objectives and metrics; lead staff toward achieving strategy and goals. • Recruit and retain appropriately qualified support staff; recommend and implement staffing decisions. • Work with individual team members to develop and maintain training, performance management plans, reviews and career plans; provide performance‑management feedback. • Plan, assign and monitor workload for QC Support personnel; identify and eliminate inefficiencies in QC support workflows. • Build and sustain technical expertise within themselves and their direct reports in QC support functions.
GMP Compliance:
• Review and approve quality documents consistent with procedure requirements, including deviations, laboratory procedures, equipment and system change controls, and compliance documentation. • Escalate critical quality or safety issues to line management in a timely manner.
Quality Systems and Customer Focus:
• Ensure QC Support teams meet customer goals related to audit readiness, compliance, turnaround times, and support to QC testing groups. • Participate in investigations; record errors and follow through on corrective actions in line with procedures and training. • Follow all relevant Environmental, Health and Safety procedures and participate in incident investigations as required.
Digital Systems:
• Design / Build / Maintain QC digital systems in collaboration with site and external Digital teams, ensuring robust system performance and data integrity for QC operations.
General Senior Manager responsibilities across site:
• Has a business management and team management role (consistent with the Senior Manager position). • People Management Role. • Performance manager / improver / coach. • Role model. • Policy administrator / decision maker. • Team builder / motivator. • Main link in the communications chain. • Business planning and implementation of business plans.
Educational Qualifications / Experience Required
• BSc, MSc or PhD in a Life Science, Engineering, or related discipline with a minimum of 3–5 years pharmaceutical/biotechnology supervisory experience. • Demonstratable knowledge of cGMPs and regulations related to QC laboratory operations, including strong understanding of equipment lifecycle management, sample management processes, training systems, and laboratory digital systems (e.g., LabVantage, MODA, NuGenesis, Binocs). • Demonstrated understanding of Data Integrity and its application in a Digital Laboratory**.**
Additional Skills / Preferences
• Proven problem‑solving and decision‑making skills in both group and individual settings. • Strong organizational skills with ability to follow assignments through to completion. • Self‑motivated, positive, and capable of leading a team under pressure. • Demonstrates flexibility and adaptability to meet business needs. • Excellent interpersonal and communication skills (written and oral). • Demonstrates a continuous‑improvement mindset. • Demonstrated initiative and ability to work proactively without direct supervision. • Ability to implement changes in technology, digital systems, and business processes. • Requires technical knowledge and understanding of how the QC Support team integrates with other QC and site functions to achieve mutual objectives. • Decision Making: Makes decisions guided by practice and precedence. • Influence: Influences peers and direct management; collaborates with direct reports to drive impact**. • **Problem Solving: Solves day‑to‑day operational and technical issues; escalates and collaborates on complex problems as needed. • Accountability and Scope: Management responsibility for a QC Support team. • Financial and Resource Management: Works within budgetary and financial objectives set by next‑level management. • Strategic Planning: Develops plans to meet short‑term departmental objectives.
Additional Requirements / Information
**• **Must be able to travel for familiarization and training as required. • May be required to work on a shift basis depending on production support needs.
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 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.
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