Principal Associate

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Job Title: Principal Associate – Quality Assurance

Location: Limerick, Ireland 

Company: Eli Lilly & Company 

About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. We are seeking highly motivated, talented Quality Assurance Associate to support our new Biologics Manufacturing Facility. The ideal candidate is an organised and a methodical professional who fosters a positive team environment. 

Main Purpose and Objectives of the Position:

Building state of the art, digitally enabled QMS and assure that the Quality System(s)/Program remains in a validated state and within regulatory commitments.  Provides Quality leadership, direction and governance for Limerick Change, Deviation Management, CAPA Business process incl. systems and compliance. Assures consistent implementation of standards across the quality system. Manages quality-related matters specific to quality systems & compliance. Is responsible for approving appropriate quality-related documents. Performs design and ongoing monitoring which includes but not limited to the following programs: 1) Monitoring of quality systems, 2) The self-inspection program 3) Verification of the effective implementation of key GMP programs 4) Review of systems that impact safety, product quality to ensure that they operate in a state of control. Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned. Provide coaching and mentoring to other QA reps, to provide appropriate and timely solutions to compliance in a business focused fashion.

Key Responsibilities:  

Co-ordinates the site program to ensure compliance with the Global Quality Standards. Drives efficiencies in this process. Ownership of Change and Deviation Management System, ensures implementation to the site of same and that it aligns with Global Quality Standards Point of contact for generation of Notification to Management for exceptions to Global Standards Report & escalate critical quality issues to appropriate level of quality management for resolution  Co-ordinate and report site compliance information and management review reports Works cross functionally to ensure site contribution to Site Compliance Report is completed and provide site context and additional analysis/information as required Working with Global Quality Systems group to ensure value-adding, right sized approach to Management Reviews and with QA Mgt to ensure management reviews are resourced appropriately Business Process owner for Change Management, Trending and Activity Planning Responsible owner of GMP documents/processes in relation to Change Control, Trend Analysis, Observation Management and GNP activity planning/tracking Review and approval of key GMP documents such as GMP standard operating procedures as appropriate to area of responsibility  Responsibility for compliance with the Global Quality Systems & local procedures  Interpretation and application of emerging Global Quality System changes, Regulatory & GMP guidelines to the specific Quality System(s)/Program  Benchmarking of current and emerging initiatives in the specific Quality System(s)/Programs. Review and approval of change controls, deviations and failure investigations. Co-ordinates Root Cause Investigator facilitator group Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.  Provide training oversight on the system of Global Quality Standards/Lilly Quality Standards Support site GMP inspections ensuring appropriate technical resources are identified to support inspections Generation and reporting metrics such as observation metrics, backlog metrics, change control metrics to senior management and for incorporation in to relevant site trending scorecards Participates in site deviation and change reviews

Basic Qualifications:  

BSc, Msc, or PhD in Biotechnology, Chem, Eng or Science related discipline with appropriate experience

Additional skills/experience:  

Minimum of 5 years’ experience in GMP operations 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, prioritization, and organizational skills. Strong understanding and working knowledge of local and international data integrity regulations, data quality management, data security and other policies/regulations as applicable. Strong and technical expertise in areas of cGMPs e.g., QC and manufacturing operations, production practices, and quality systems 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. Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment. Positive Influence : Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve. Demonstrated success in influencing without authority. Relationship Builder : Demonstrated ability to establish and maintain key relationships across all levels in the organization. Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues. 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. Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership. Ability to communicate effectively with all levels and functions in the organisation. Strong collaboration with colleagues at all levels 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 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.

#WeAreLilly

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