Principal Associate – Quality Auditor

Eli Lilly and Company

. Schedule, prepare, conduct, and report GQA audits and assessments of internal and external GCP operations .

Posted 10/13/2026full-timeRemote • SingaporeMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GCP operations, compliance assessment, and quality management within the pharmaceutical industry. Proficient in conducting audits, risk assessments, and maintaining regulatory knowledge while fostering effective stakeholder relationships.

Highest-signal resume keywords

GCP Compliance AssessmentAudit Preparation and ReportingRisk Assessment LeadershipRegulatory InterpretationProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP OperationsQuality ManagementData AnalysisRegulatory ComplianceScientific Information InterpretationSix Sigma MethodologyDatabase ManagementAudit Metrics PreparationTraining and QualificationInterpreting Corporate Guidelines

Soft Skills

Excellent Interpersonal SkillsStrong Communication SkillsAnalytical Problem-SolvingAbility to Manage Multiple TasksConstructive Feedback Provision

Industry Keywords

Pharmaceutical EnvironmentThird-Party Organization CollaborationGlobal Team ExperienceRegulatory GuidanceQuality Standards

About the role

Key responsibilities & impact

Schedule, prepare, conduct, and report GQA audits and assessments of internal and external GCP operations
Assess compliance with company standards, policies, practices, procedures, regulations, and guidelines
Participate in or lead risk assessments of GCP operations for the risk-based annual audit plan
Escalate compliance issues appropriately
Maintain knowledge of applicable regulations, technical requirements, and training standards
Participate in or lead preparation and review of quality standards, policies, procedures, and guidelines
Prepare organizational metrics and trend audit findings
Advise GCP operations on interpreting corporate and regulatory GCP requirements related to quality management
Complete required training and remain current on industry trends and regulatory interpretations
Share GCP knowledge with colleagues and support auditor training and qualification
Participate in or lead divisional improvement efforts, including Six Sigma projects and departmental teams
Establish effective relationships with internal and external stakeholders

Requirements

What you’ll need

Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, or another relevant technical area
Minimum of 5 years of relevant experience within the GCP area at Lilly or within the pharmaceutical environment
Experience working with third-party organizations
Ability to understand detailed scientific information while remaining focused on the broader picture
Ability to interpret and apply regulations, regulatory guidance, codes, public expectations, and compliance changes
Excellent interpersonal skills and ability to remain constructive and civil in difficult situations
Ability to deliver timely, precise, and clear oral and written communications to all organizational levels
Experience working on a global team and sharing knowledge
Experience with computers and entering data into databases
Good analytical and problem-solving skills
Strong communication skills in English, speaking and writing
Ability to travel domestically and internationally up to 40%, including trips lasting 1–2 weeks and sometimes arranged on short notice
Business communication skills in Japanese, speaking and writing, are an added advantage
Ability to manage multiple concurrent tasks and deadlines in a fast-paced environment
Process perspective and project management skills
Ability to work independently and collaboratively in a global team environment
Ability to provide constructive customer feedback and manage change or conflict

Benefits

Comp & perks

Disability accommodation support during the application process
Equal opportunity and nondiscrimination commitment
Professional development through training courses, conferences, or association meetings
Required role training through the Individual Training Plan (ITP)
Opportunity to participate in Six Sigma projects and departmental improvement teams