Medicines Quality Consultant P1-P3

Job Description

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 39,000 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 Description for Medicines Quality Consultant (MQC), Medicine Quality

Organisation (MQO)

Purpose:

The purpose of the Medicines Quality Consultant (MQC) role is to support the development and implementation of quality systems strategy and activities to support MDU goals and objectives for assigned countries. In support of this mission, the purpose of the role of MQC for an Affiliate is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The MQC will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements. The MQC will provide updates on internal/external GxP trends and changes through Affiliate Integrated Quality Lead Team (IQLT) (where applicable).The MQC will act as a contact person regarding quality and business process compliance concerns between affiliates and global.

Responsibilities:

Ensure local implementation of the Safety and Efficacy Quality System (SEQS)

• Review regional and/or local SOPs versus global policies. Reviews SEQS documents and provides feedback
• Approve regional and/or local procedures, required tools, forms, templates
• Recommend new procedures or changes to existing procedures where applicable
• Provide quality oversight for compliance to SEQS
• Escalate compliance issues to management locally and globally as appropriate
• Provide support for outsourced activities in alignment with internal standards

Ensure inspection readiness and compliance to global, regional, and/or local regulations

• Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates
• Perform quality self-assessments
• Facilitate audits and inspections
• Coordinate audit responses including Trackwise system documentation
• Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc.

Ensure the implementation and maintenance of regional and/or affiliate Quality Plan(s)

• Document the regional and/or affiliate quality systems requirements ensuring clear accountabilities
• Manage the regional and/or affiliate quality plan(s)
• Provide updates to quality and business owners

Implement and manage Quality Systems

• Provide consultation on the integration of quality into business processes
• Support the business on the application and facilitation of quality systems (deviations, notification to management, change control)
• Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process

Drive trending of metrics to improve processes and compliance

• Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions
• Monitor completion of deviations, CAPA related to deviations and change controls
• Monitor completion of audit responses through metrics
• Provide updates to management
• Share key learning to drive simplification and replicate best practices in the region and globally
• Coordinate quality improvement initiatives
• Seek and implement simplification and process improvement

Other responsibilities

• Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
• Understand the roles and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV)

Minimum Qualification Requirements:

• • Bachelors or Masters Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse
  • Three years experience in quality and/or drug product safety/regulatory
  • Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GMP, GCP, GVP etc.)
  • Demonstrated ability to communicate effectively, both written and verbal, and to influence others
  • Demonstrated ability to prioritize and handle multiple concurrent tasks
  • Demonstrated ability to apply risk-based decision making in a regulated environment

Other Information/Additional Preferences:

• • Demonstrated ability to work in a global environment
  • Ability to travel
  • Cultural sensitivity

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.