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Senior Scientist Compliance Specialist

2 months ago

Indiana, Pennsylvania, United States Eli Lilly Full time
About the Role

We are seeking a highly skilled Senior Scientist Compliance Specialist to join our team at Eli Lilly. As a key member of our Quality Control department, you will play a critical role in ensuring the compliance of our laboratory operations with regulatory requirements and global quality standards.

Key Responsibilities
  • Interpret regulatory requirements and global quality standards to develop and maintain local paper-free, digital-enabled systems, processes, and procedures.
  • Ensure internal and external compliance requirements, including data integrity requirements, are incorporated into lab systems and processes.
  • Monitor GMP and compendial compliance.
  • Own the GMP readiness plan for the labs to ensure a consistent and compliant approach across all laboratories during start-up.
  • Design, implement, maintain, and own the analytical equipment lifecycle management process, including oversight of third-party service providers providing support for equipment lifecycle activities.
  • Implement the QCL Training/Personnel Qualification Strategy for start-up and subsequent phases, ensuring alignment with site policies and procedures.
  • Serve as QC SME for lab processes such as equipment qualification, lab investigations, personnel qualification, etc.
  • Work with central functions in the development and delivery of 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.
  • Author/review key GMP documents such as GMP standard operating procedures, training materials, test methods, qualification documents, lab/equipment/computer system periodic reviews, annual product reviews, validation master plans, etc.
  • Process owner for lab-specific GMP service providers.
  • Lead the QC inspection readiness program.
  • Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities and Food and Drug Administration.
  • Collate QC compliance metrics and make recommendations to management on actions.
  • Provide ongoing education, coaching, feedback, and mentoring to QC personnel as it relates to execution of quality systems.
  • 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 the use of digital solutions for data, equipment, and laboratory management.
  • Experience with regulatory inspections.
  • 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.
Preferred Skills
  • Strong written and oral communication skills.
  • Excellent attention to detail.
  • Ability to work independently, self-sufficiently, and proactively in the performance of work duties.
  • Ability to influence others to implement changes in the minimum time.
  • High learning agility and flexibility to achieve the required outcomes.
  • Imaginative approach to problem-solving and solution discovery.