Principal Associate – Quality Auditor

This is a fully remote position, open to applicants in Singapore.

📋 Description

• Schedule, prepare, execute, and report on GQA audits and evaluations of both internal and external GCP operations.

• Evaluate compliance with company standards, policies, practices, procedures, regulations, and guidelines.

• Engage in or lead risk assessments of GCP operations as part of the risk-based annual audit plan.

• Appropriately escalate compliance concerns.

• Stay informed about relevant regulations, technical requirements, and training standards.

• Participate in or lead the preparation and review of quality standards, policies, procedures, and guidelines.

• Prepare organizational metrics and analyze audit findings trends.

• Advise GCP operations on the interpretation of corporate and regulatory GCP requirements related to quality management.

• Complete necessary training and keep abreast of industry trends and regulatory interpretations.

• Share GCP knowledge with colleagues and assist in auditor training and qualification.

• Engage in or lead divisional enhancement initiatives, including Six Sigma projects and departmental teams.

• Build effective relationships with both internal and external stakeholders.

⛳️ Requirements

• Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, or another relevant technical field.

• At least 5 years of relevant experience in the GCP domain at Lilly or within the pharmaceutical sector.

• Experience collaborating with third-party organizations.

• Ability to comprehend detailed scientific information while maintaining a focus on the broader perspective.

• Competence in interpreting and applying regulations, regulatory guidance, codes, public expectations, and compliance modifications.

• Strong interpersonal skills with the ability to remain constructive and courteous in challenging situations.

• Capability to deliver timely, accurate, and clear oral and written communications across all organizational levels.

• Experience working within a global team and sharing expertise.

• Proficient in computer use and data entry into databases.

• Solid analytical and problem-solving abilities.

• Proficient communication skills in English, both spoken and written.

• Willingness to travel domestically and internationally up to 40%, including trips of 1–2 weeks, sometimes arranged on short notice.

• Proficiency in business communication in Japanese, both spoken and written, is a plus.

• Ability to manage multiple concurrent tasks and deadlines in a fast-paced environment.

• Process-oriented perspective and project management capabilities.

• Capacity to work independently and collaboratively in a global team setting.

• Ability to provide constructive feedback to customers and manage change or conflict effectively.

🏝️ Benefits

• Support for disability accommodations during the application process.

• Commitment to equal opportunity and nondiscrimination.

• Opportunities for professional development through training courses, conferences, or association meetings.

• Required role training provided through the Individual Training Plan (ITP).

• Chance to participate in Six Sigma projects and departmental improvement teams.