Senior Associate

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.

Job Title:

Senior Associate - QA Materials Management

Location:

Full-time on site in Raheen, Limerick, Ireland

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 methodical professional who fosters a positive team environment.

Main Purpose and Objectives of the Position:

1. Provides Quality leadership, direction and governance for materials management.
2. Assures consistent implementation of standards across the quality system.
3. Manages quality-related matters specific to Material Operations.
4. Is responsible for approving appropriate quality-related documents.
5. Performs ongoing monitoring that includes:

1. Monitoring of quality systems,
2. Materials Management area time on floor (TOTF) audits, self-inspection program
3. Verification of the effective implementation of key GMP programs
4. Review of systems that impact Product Quality to ensure that they operate in a state of control.

7. Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
8. Continue to provide coaching and mentoring to operations personnel and to other QA reps, on the appropriate risk management to provide appropriate and timely solutions to compliance in a business-focused fashion.

Key Responsibilities:

1. Develop and implement Quality system for materials management including, SOPs, Quality agreements and risk assessments.
2. Review and approval of change controls, deviations, failure investigations, product quality complaints associated with the area(s) of responsibility.
3. Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
4. Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for equipment, computer systems, logbooks, processes and periodic product quality evaluations as appropriate to area of responsibility.
5. Review and approval of other key GMP documents such as GMP standard operating procedures, sample protocols, splitting documents as appropriate to area of responsibility.
6. Understand the Global Quality Standards/Common Quality Practice and how they apply to the process team.
7. Participate in quality risk management activities such as FMEAs. Assess the impact on product quality of issues associated with materials and consumables.
8. Audit & participation in the Site Self-Inspection program of the area(s) of responsibility for compliance with the Product Quality System policies, procedures and guidelines.
9. Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility.
10. Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.
11. Contribution to the GMP Plan for Materials Management Initiatives.
12. Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
13. Assess the impact on product quality of quality deviations associated with the process team.
14. Assure robust Root cause Analysis and effectiveness of investigations.
15. Responsible for Batch Disposition (re-identifications / re-evaluations), including approval of raw materials and packaging components (manual disposition when required) used in the manufacture of drug substance products.
16. Assurance that the Quality System(s)/Program remains in a validated state and within regulatory commitments.
17. Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program.
18. Support slow moving inventory and product discontinuation initiatives.
19. Facilitate compliance with process team commitments such as deviation cycle time, backlog etc.
20. Liaison between process team and other quality areas.
21. Benchmarking of current and emerging Materials Management initiatives.
22. Develop personal knowledge about the manufacturing process of the product(s) including but not limited to facilities, procedures, people expertise and quality systems.
23. Ensure the required relevant knowledge and experience/training necessary to fulfil duties is acquired.
24. Re-identification of damaged material if undamaged portion of a lot is to be used.
25. Responsible for providing quality support in relation to packaging and supply chain cover.

Basic Qualifications:

1. BSc, M.Sc., or PhD in Science, Engineering, or related discipline with appropriate experience.

Additional skills/experience:

1. Minimum of 5 years' experience in GMP operations.
2. 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.
3. Strong understanding and working knowledge of local and international data integrity regulations, data quality management, data security and other policies/regulations as applicable.
4. Strong and technical expertise in areas of cGMPs e.g., QC and manufacturing operations, production practices, and quality systems including maintenance processes is preferable.
5. 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.
6. 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.
7. 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.
8. Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
9. 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.
10. 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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