Lilly Quality Auditor Advisor - Global Quality Auditing and Compliance (GQAAC) in Utrecht, Netherlands
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Quality Auditor Advisor - Global Quality Auditing and Compliance (GQAAC)
Location: Any European Lilly Office
Position Brand Description:
The Quality Auditor - Advisor is part of the Global Quality Auditing and Compliance (GQAAC) 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 and technical knowledge, the Quality Auditor - Advisor 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.
GQAAC 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 - Advisor plays a key part in contributing to the technical strategy and implementation of this approach to quality auditing oversight.
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
Leverage external knowledge and technical experience to influence decisions with broad network/functional impact:
Provide technical input and recommendations into escalations and instances of non-compliance.
Provide technical input and review of the annual audit plan.
Review of GxP metrics for areas of risk and propose appropriate audit mitigation strategies.
Enable successful implementation of GQAAC Management/Lead team technical strategies and improvements.
Serve as an ad hoc participant of GQAAC lead team meetings to provide technical guidance and consultation, as needed.
Plan and lead complex audits and audit teams. Lead, schedule, prepare, conduct and report GQAAC audits and assessments of GXP operations and data integrity, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.
Participate, prepare, conduct and report on cross-functional audits across multiple GxP and/or business areas.
Participate in or lead in the risk assessment of research or commercial operations in support of generating the GQAAC risk-based annual audit plan.
Appropriately escalate any compliance issues.
Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
Educate business areas and leadership regarding impact of quality and data integrity issues and influence the development of robust corrective and preventative actions to address.
Global Quality – Business Related Responsibilities:
Identify the need and drive the revision of GQAAC quality system documents when appropriate. 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 research and commercial operations on the interpretation of corporate and regulatory GxP requirements (standards/policies/procedures) related to quality management, when required.
Establish and maintain relationships with relevant business areas and regulatory authorities, including facilitation and hosting of regulatory inspections, when required.
Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
Actively participate in external activities that build influence in areas relevant to the business.
Provide GXP technical mentorship and training to individuals within and external to the organization
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 GxP requirements.
Seek self-development in GxP areas (e.g., grand rounds, 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.
Execution of this work by the Quality Auditor - Advisor requires limited supervision. This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations and industry practices / state of the art, deep and breadth technical knowledge in the area(s) of responsibility, and a senior auditor’s approach of continuous self-development and fulfillment of training needs.
Bachelor's Degree (or equal work experience) in Physical or Biological Sciences, Engineering or other Technical areas.
In-depth,advanced experience and proven success working within GxP areas within a pharmaceutical environment.
Experience working with Third Party Organizations.
The 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.
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.
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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.