Principal Associate-Quality Auditor–GQA

Overview

Principal Associate, Quality Auditor (GCP) within Global Quality Auditing (GQA), providing quality assurance through internal and external audits of GXP operations supporting pharmaceutical development, clinical research, pharmacovigilance and consumer information quality.

What you'll do

• Schedule, prepare, conduct and report GQA audits and assessments of GCP operations, internal and contracted, to assess compliance with company standards, policies, procedures and current regulations and guidelines.
• Participate in or lead risk assessment of GCP operations to support the risk-based annual audit plan.
• Escalate compliance issues appropriately.
• Meet requirements in quality standards, quality manuals, policies, procedures and tools, maintaining comprehensive knowledge of applicable regulations, technical knowledge and training.
• Participate in or lead preparation and/or review of standards, policies, procedures and guidelines establishing quality requirements, when needed.
• Participate in or lead preparation of organizational metrics and trending of audit findings, when required.
• Provide audit-related advice to GCP operations on interpreting corporate and regulatory GCP requirements related to quality management, when required.
• Maintain good interpersonal and communication skills with auditees and business areas, with emphasis on verbal and technical writing.
• Complete required training in the Individual Training Plan (ITP).
• Stay aware of current industry trends and regulatory agency interpretation of GCP requirements, and seek self-development in GCP areas and share knowledge with the group.
• Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
• Support training and qualification of other auditors.

What you'll need

• Bachelor's Degree (or equivalent work experience) in physical or biological sciences, or other 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 anchored in the "Big Picture."
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate.
• Excellent interpersonal skills, with ability to remain constructive and civil in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• 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, writing).
• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced environment with frequent interruptions and changing priorities.
• Proven ability to think and analyze from a process perspective.
• Project management skills.
• Process information to identify linkages and trends and apply findings to compliance strategies and individual assignments.
• Work independently as well as collaboratively within a global team environment.
• Deliver constructive feedback to customers while providing a high level of customer service.
• Ability to influence and manage change and conflict.
• Establish and maintain effective working relationships at all levels, internal and external to Lilly.
• Ability to think on your feet and be pragmatic in decision-making.

Nice to have

• Business communication skills in Japanese (speaking, writing).

Details

• Position location: Singapore, Remote.
• Domestic and international travel required, up to 40% (duration 1-2 weeks), sometimes on short notice.