Advisor - Quality-SQM, Materials & Internal Audits

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Job description

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 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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

The Quality Advisor-SQM, Materials & Internal Audits is responsible for ensuring that the materials and services provided by suppliers meet the quality standards and specifications as well as management of the site's internal audit program. The quality advisor will also monitor and evaluate the performance of suppliers through periodic performance reviews and metrics. This role is expected to contribute to the overall achievement of the company's strategic goals by providing front line support in the identification and resolution of quality issues, implementing continuous improvement initiatives.

The Quality Adviser will collaborate with Global Auditing and Compliance, Procurement, Laboratory, Engineering and Production teams to ensure audit schedules, internal audits, materials and services are completed and or delivered on time and in compliance with regulatory and quality agreements. The role is also expected to host and or support audits and regulatory inspections.

Responsibilities:

Site Quality- SQM Business Related Responsibilities:

• Own develop and maintain supplier quality management procedures and guidelines.
• Support supplier audits, assessments and inspections to verify compliance with quality standards and specifications.
• Lead the site internal audit/ self-assessment program
• Deploy quality risk management principles to ensure appropriate risk mitigation and controls exercised.
• Analyze and report supplier quality performance, trends, risks.
• Initiate and facilitate corrective and preventative actions for quality issues or non-conformances.
• Provide technical guidance and support for laboratory, procurement, engineering and production teams on materials and services selection, evaluation and qualification.
• Provide management and oversight of SCARs, SCNs, Qualifications and Periodic Performance Reviews.
• Collaborate with internal and external stakeholders to ensure alignment and coordination of SQM activities and objectives.
• Provide and monitor developed KPI's
• This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Materials Management Certification Program:

• Own and maintain overall responsibility for the Materials Management Certification Program.
• Lead the Materials Review Board.
• Ensure materials are received, tested and released in a timely manner while ensuring testing requirements are met. (e.g. compendia, USP, EP, Health Canada)
• Own site actions associated with sample management and various material related initiatives.
• Serve as the primary QA resource for material specifications for creation and update.
• Maintain site sample management metrics and track status of the samples in collaboration with laboratory and MRB.
• Own the responsibility for enhancing and sustaining sample management and integrity of testing.
• Develop a comprehensive continuous improvement roadmap to ensure the site keeps up to date with regulatory expectations, industry best practices, etc.
• Participate on global material board teams to ensure site aligns with other internal facilities.

Internal Auditing:

• Scheduling, preparing, conducting and reporting local internal audits to assess the level of compliance with established standards and current regulations and guidelines (leading audit teams etc.).
• Serve as a Liaison to GQAAC regarding issues with suppliers and materials.
• Collaborate with GQAAC for complex SQM audits. ("for-cause").
• Follow-up with internal stake holders to ensure corrective actions are taken to satisfactory close audit observations.
• Appropriately escalate any compliance issues.
• Meet the requirements defined in quality standards, quality manuals, policies, procedures, and tools.
• Based on need and employee development, complete required actions to participate on global SQM (GQAAC) audits if requested.

Personnel Development:

• Support training to less experienced supplier quality staff and business partners.
• Serve as a mentor and proactive coach for others within the organization. Be considered as a person of reference within the function for technical and auditing advice.
• Maintain good interpersonal and communication skills with auditees and business areas with emphasis on verbal and technical writing skills.
• Complete required training and qualifications for the roles identified in the Learning Plan.
• Be continually aware of current industry trends and regulatory agency interpretation of requirements.
• Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
• Actively participate in external activities that build influence in areas relevant to the business.
• Provide technical input and recommendations into audit observations via Audit Review Board.
• Provide technical input and recommendations into material qualification and management via Material Review Board.
• Leverage external knowledge and technical experience to influence decisions with broad network/functional impact.

Basic Requirements:

• Bachelor's degree or higher in the sciences, engineering, or related field (or equivalent work experience) required.
• 10+ years of experience in cGMP operations required.
• Demonstrated successful leadership of cross-functional teams and project management experience
• Good knowledge of cGMP, external Regulations and SQM and material testing requirements
• Strong Influencing Skills and interpersonal and teamwork skills
• Strong self-management and organizational skills
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Preferences:

• Experience in Quality Assurance, Quality Control, Operations, Engineering or Technical Services, Auditing
• Work independently as well as collaboratively within a global team environment
• Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced
• work environment with frequent interruptions and changing priorities.
• Project Management Skills.
• 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 and to the suppliers.
• Good analytical/problem-solving skills. Pragmatic decision making.
• Proven ability to think and analyze from a process perspective. Project management skills.
• Establish and maintain effective working relationships at all levels internal and external to Lilly.
• Deliver constructive feedback to customers while providing a high level of customer service.
• Ability to influence and manage change/conflict.

Additional Information:

Physical Demands/Travel:

The physical demands of this job are consistent with a manufacturing setting; 15-25% Travel (domestic and international) may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position's work environment is in a manufacturing setting

To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 ( ) 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.
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