Principal Associate-Quality Auditor–Gqa

About Lilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This job posting is for a GCP Medical Auditor based remotely in Singapore.

JOB POSITION OVERVIEW

The Quality Auditor is part of the Global Quality Auditing (GQA) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance, and consumer information quality (CIQ) for Lilly. Through auditing, the Global Quality Auditor assures that GXP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards. GQA is operating as a valued business partner and taking a proactive approach to further enhancing the quality status of business operations and regulatory compliance. The Quality Auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.

RESPONSIBILITIES

The following activities will be performed according to current GQA procedures, guidelines, and tools. These responsibilities are not intended to be all-inclusive:

1. Auditing:

• Scheduling, preparing, conducting, and reporting GQA audits and assessments of GCP operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
• Participate in or lead the risk assessment of GCP operations in support of generating the GQA risk-based annual audit plan.
• Appropriately escalate any compliance issues.
• Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools. This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

2. Global Quality – Business Related Responsibilities:

• Participate in or lead the preparation and/or review of standards, policies, procedures, and guidelines that are used to establish quality requirements, when needed.
• Participate in or lead the preparation of organizational metrics and trending of audit findings, when required.
• Provide audit-related advice to GCP operations on the interpretation of corporate and regulatory GCP requirements (standards/policies/procedures) related to quality management, when required.

3. Personnel Development:

• Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
• Complete required training for the roles identified in the Individual Training Plan (ITP).
• Be continually aware of current industry trends and regulatory agency interpretation of GCP requirements.
• Seek self-development in GCP areas (e.g., attend training courses, conferences, or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.
• Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
• Support training and qualification of other auditors.

BASIC QUALIFICATIONS

• Education Level: Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, or other relevant technical area.
• Experience:
  • Relevant experience(s) (minimum of 5 years) within the GCP area at Lilly or within the pharmaceutical environment.
  • 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, 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/problem-solving skills.

REQUIRED INFORMATION

• Position Location: Singapore Remote
• Language capabilities: Strong communication skills in English (speaking, writing); Business communication skills in Japanese (speaking, writing) are an added advantage.
• Travel Percentage (%): Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice.

ADDITIONAL SKILLS/ PREFERENCES

• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work 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 as well as to 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/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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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. #WeAreLilly