Sr. Advisor, GQA

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.

Additional information

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

• Participates in external activities that build influence in areas relevant to the business.
• Provide 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.
• Attend training courses, conferences or association meetings to continue to gain knowledge in GxPs and to share such information with other members of the group or company to increase their awareness.
• Mentor others in the implementation of GxP requirements.
• Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.

Minimum Requirements

• Bachelor's degree in physical or biological sciences, engineering or a related scientific/technical discipline.
• Minimum of 10 years of experience within the pharmaceutical industry working in a GCP/GLP area.
• Minimum of 5 years of experience working with Third Party Organizations, such as CROs, Clinical Vendors/Service Providers, Pre-Clinical/Clinical/GLP Labs, Clinics, and clinical supply organizations.
• Minimum of 5 years of experience reviewing/assessing/auditing Pre-Clinical/Clinical data/reports.

Additional Skills/ Preferences

• ASQ Certified Quality Auditor (CQA)
• 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.
• 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.

Additional Information

• 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 information

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GxP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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