Senior Global Quality Auditor

Sr. Principal Associate - Quality Auditor

The Sr. Principal Associate - Quality Auditor 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, the Sr. Principal Associate - Quality Auditor assures that GXP operations conducted and sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.

GQAAC has adopted a proactive approach to ensure the effective implementation of a continuous quality assurance program. This program has the objectives of guaranteeing compliance with regulations in all geographies where Lilly operates and of further enhancing the quality of operations of Lilly and their contracted parties. The Sr. Principal Associate - Quality Auditor is an expert quality professional, acting as a key contributor to the development and execution of the GQAAC audit program within the GXP area(s) of responsibility.

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

Auditing

Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. This includes leadership of audit teams including GXP- and ability to successfully execute a portfolio of complex audits as lead or solo auditor, as appropriate (e.g. : for cause, process and system audits, affiliates, large TPOs and pre-inspection audits). Performance of this work requires limited supervision.

Participate in mock-inspections, as appropriate.

Participate or lead the risk assessment of research and commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across GQAAC and the business areas involved / impacted.

Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.

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

Global Quality Business Related Responsibilities

Identify the need and drive the revision of GQAAC quality system documents when appropriate. 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 advice to research and manufacturing operations on the interpretation of corporate and regulatory GXP requirements, when required.

Establish and maintain relationships with relevant regulatory authorities, including supporting or facilitation of regulatory inspections, when required.

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

Influence internal and external customers and partners when improvement needs are identified.

Continuous Improvement Related to Role

Participate in the continuous improvement agenda related to the role to ensure compliance within a continually changing company, regulatory and industry landscape.

Represent assigned process within broader change and transformation initiatives.

Partner with GPhV risk assessor to drive innovation, simplify and standardize audit processes, including implementation of risk-based paper-based audit programs, where appropriate.

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

Personal Development

Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.

Complete required training identified in the Individual Learning Plan.

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.

Mentor others in the implementation of GXP requirements.

Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.

Act as a proactive coach for others within the organization : focused on systematic execution under highest standards of quality. The Sr. Principal Associate - Quality Auditor is considered a person of reference within the function / team for technical and general auditing advice.

Minimum Requirements

Bachelors Degree - Preferred degree in physical or biological sciences, or other technical area.

Minimum of five (5) years' experience related to Pharmacovigilance (PV) or pharmaceutical industry.

Additional Preferences

Experienced in working with Third Party Organizations.

Ability to analyze detailed technical scientific information, while understanding the bigger picture. The senior auditor should be able to clearly identify and assess risk and impact associated with specific and overall findings and situation for an auditable unit, event or case, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations.

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.

Experienced in working on a global team and sharing knowledge.

Experience with computers, entering and managing data in databases.

Good analytical / problem-solving skills.

Ability to handle several complex projects in parallel.

Systematic approach to ensure self-safety and that of the audit team.

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.

Ability to think on your feet and be pragmatic in decision making.

Other 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.