We're seeking individuals driven to improve life for people worldwide.
Lilly is building a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This state-of-the-art facility will utilize cutting-edge technologies and advanced data collection platforms, enhancing safety, quality, productivity, and process performance. As part of the technical team, you'll contribute to the successful startup of this greenfield manufacturing site.
Job Overview
The Senior Scientist Compliance role provides technical support for Quality Control laboratory compliance systems. Responsibilities include interpreting regulations, designing, implementing, and maintaining laboratory quality systems, ensuring internal and external compliance requirements are met.
* Develop and maintain digital systems, processes, and procedures adhering to global quality standards and regulatory requirements.
* Monitor GMP and compendial compliance, ensuring data integrity is maintained throughout.
* Owning the GMP readiness plan for laboratories, promoting a consistent and compliant approach across all labs during startup.
* Design, implement, and maintain analytical equipment lifecycle management, overseeing third-party service providers.
* Implement the QCL Training/Personnel Qualification Strategy, aligning with site policies and procedures.
* Serve as QC SME for lab processes, such as equipment qualification, lab investigations, personnel qualification, etc.
* Collaborate with central functions to develop standardized processes and procedures in QC.
* Perform/support change controls, deviations, and root cause investigations, RCI SME/mentor for QC.
* Identify and implement appropriate CAPAs.
* Autor/review key GMP documents, including SOPs, training materials, test methods, qualification documents, lab/equipment/computer system periodic reviews, etc.
* Process owner for lab-specific GMP service providers.
* Lead the QC inspection readiness program.
* Support/participate in self-inspection or other audits, focusing on analytical aspects of cGMPs.
* Collate QC compliance metrics, recommending actions to management.
* Provide ongoing education, coaching, feedback, and mentoring to QC personnel.
* Serve as QC Quality risk management facilitator and SME.
Requirements
* Safety-first approach to activities.
* Proficient in English.
* Technical expertise in analytical equipment lifecycle management, compendial requirements for lab equipment, and testing.
* Understanding of data integrity requirements in a QC environment.
* Highly competent in digital solutions for data, equipment, and laboratory management.
* Experience with regulatory inspections.
Qualifications
* Hons Degree Qualified – B.Sc. in Analytical Chemistry, Chemistry/Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience.
Key Attributes
* Business Knowledge: High performance delivery, self-management, prioritization, and organizational skills.
* Learning agility and Curiosity: High learning agility, flexibility, and ability to deal with ambiguity and uncertainty.
* Positive Influence: Demonstrated ability to address issues, trusted in the team to follow through on actions.
* Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization.
* Ability to lead people: Demonstrated ability to influence peers and across functions.
* Communication: Strong written and oral communication skills, 1:1 and group situations.
* Decision Making: Ability to be decisive, make well-informed decisions for the benefit of the team.
Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.