Hybrid Senior Principal Associate – Global Quality Auditing and Compliance

at Eli Lilly and Company

• Job title: Senior Principal Associate – Global Quality Auditing and Compliance
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Basingstoke, United Kingdom

About the role

• Quality auditor assuring compliance with pharmaceutical regulations through audits and assessments. Supporting Lilly's global quality auditing and compliance initiatives with a focus on GMP operations.

Responsibilities

• Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain comprehensive knowledge of applicable regulations, technical knowledge, and training.
• Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP operations.
• Lead or participate in risk assessments and mock regulatory inspections of GMP operations.
• Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting.
• Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality.
• Exhibit interpersonal skills relevant to auditing, such as listening, questioning, being tactful, and handling conflict constructively.
• Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.
• Participate and/or support GQAAC self-assessments or regulatory inspections.

Requirements

• Minimum of five (5) years' experience related to the pharmaceutical industry.
• Strong working knowledge of global regulations and guidelines (e.g., FDA, EU, and industry standards (e.g., ICH, ISPE, PIC/s) for GMP operations).
• Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).
• Capacity to produce high quality results across multiple projects and demands, through effective prioritization.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Excellent personal skills, including motivation, self-management, commitment, and the ability to work well with others.
• Excellent teamwork skills, including being open-minded and flexible to adopting new ideas.
• Strong project management skills to manage projects at various stages and effectively multi-task.
• Ability to maintain a flexible work schedule and adapt quickly to accommodate audit program priorities and other business-related priorities.
• Working knowledge of Microsoft office 365 suite and other business programs (e.g., document management systems, quality management systems).

Benefits

• Domestic and international travel is required to fulfill these job responsibilities.
• Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce.
• Equal opportunities when vying for positions.