Sr. Advisor GQA

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.

** Responsibilities:*
* The Senior Advisor is part of the Global Quality Auditing (GQA) division and provides quality assurance through the execution of internal and external audits and assessments in support of pharmaceutical development, non-clinical and clinical research, business development, product commercialization, and pharmacovigilance for Lilly.  Through auditing and technical knowledge, the Senior Advisor assures that GxP operations conducted or sponsored by Lilly or part of a business development project, 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 Senior Advisor plays a key part in contributing to the technical strategy and implementation of this approach to quality auditing oversight.

** Key Objectives/Deliverables:*
* Leverage external knowledge and technical experience to influence decisions with broad network/functional impact:

+ Perform audits and assessments to identify risks and provide technical input and mitigations/recommendations into escalations and instances of non-compliance.

+ Review of GxP metrics for areas of risk and propose appropriate audit mitigation strategies.

+ Enable successful implementation of GQA Management/Lead team technical strategies and improvements.

+ Serve as an ad hoc participant of GQA lead team meetings to provide technical guidance and consultation, as needed.

Auditing:

+ Plan and Lead complex audits and assessments.  Lead, schedule, prepare, conduct and report GQA audits and assessments of business development projects, research 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.

+ Appropriately escalate any risks and compliance issues.

+ Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.

+ Participate, prepare, conduct and report on cross-functional audits across multiple GxP and/or business areas.

+ 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.

This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Global Quality - Business Related Responsibilities:

+ Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.

+ Participate or lead the preparation of organizational metrics and trending of audit findings, when required.

+ Provide audit-related advice to research 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 of regulatory inspections, when required.

+ Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.

Personnel Development:

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