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.

Position Title:    Associate Director-Quality Control Laboratories

Reporting To:    Senior Director QC laboratories

Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup of GMP operations. 

Main Purpose and Objectives of Position:

Provides leadership, direction and governance for the Limerick QCL facility
Recruits and develops team members to deliver scientific excellence in analytical sciences.
Develops future leaders within the function and facility.
Manages one of the QCL teams (Bioanalytical, Chemistry, Microbiological, QCL systems and compliance or Expansion project) to ensure delivery of operational and scientific excellence.
Has a business management, site management and team management role (consistent with the Associate Director position across site)

Specifically during the startup phase of the Limerick site leadership will be expected to be a collaborative, inclusive, energetic leader and support the broader Limerick team to:

Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.
Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach
Support the project team as they deliver the facility and expansion to the site team, by providing feedback and support on decisions and strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.

Educational Requirements/ Pre-requisites:

May hold BSc, MSc, or PhD in Chemistry, Microbiology, Biochemistry, Engineering or related discipline.
Minimum 3 years of management experience of a GMP QC Laboratory.
Preferred 8+ years of experience in leadership of a cross functional team.

Key Responsibilities:

People Management:

Recruits top talent to ensure the delivery of operational and scientific excellence in the field of analytical sciences.
Provides routine coaching and feedback to team members and peers to enable them to attain their maximum potential.
Ensures the key support systems associated with training and development, performance management and career management are in place for all team members.

GMP Compliance:

Responsible for review and approval of specific quality documents consistent with cGMP requirements; including, but not limited to, safety and quality SOPs, validation protocols and reports, analytical methods, change controls, investigations and deviations etc.
Responsible for the escalation of critical quality and safety issues as appropriate to line management.

Operational Excellence and Customer Focus:

Responsible for the QCL Unit meeting customer service level agreements. These agreements will detail safety, quality and cycle time metrics associated with all activities performed by the team.
Champions the use of lean tools and systems to ensure delivery of service level agreements.

Technical Excellence:

Ensures all team members have the required knowledge and expertise to undertake their role.
Ensures all methods and equipment used in the provision of scientific information have the required accuracy and precision to support customer needs.
Responsible (directly or indirectly) for the provision analytical input to development, execution and reporting of cross functional scientific studies and/or key operational issues.

Corporate/Site Strategy and Mission:

Supports the organisation through expense, capital, headcount, and project business planning and aligning with various sites and corporate business plans in respect of GMP and compliance requirements and standards.

Key Attributes :

Business Knowledge : High performance in delivery of their work. Looks at better, simpler ways , takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills.

Learning agility and Curiosity : High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions.

Positive Influence : Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.

Relationship Builder : Demonstrated ability to establish and maintain key relationships across all levels in the organisation.

Ability to lead people : Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.

Communication : Demonstrated strong communication skills, written and oral in 1:1 and group situations.

Decision Making : Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.

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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Associate Director - Quality Control Laboratories

Job Description