Director, Quality - Sterility Assurance

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 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.

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.

The purpose of this position is to act as a subject matter expert for sterility assurance and microbiology within the Quality organization. This individual in this role operates cross-functionally to develop approaches and to drive harmonization of practices in the parenteral network (PPN). The sterility assurance director drives the development of sterility assurance knowledge in the PPN sites ensuring technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. This role assists sites with trouble shooting and peer reviews for significant sterility assurance topics. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This position acts as a Q functional member in the PPN governance bodies as appropriate.

Responsibilities:

Operate cross-functionally to develop approaches and drive harmonization projects across the parenteral network for sterility assurance and microbiological related topics.

Work closely with site and cross-functional SMEs to drive cohesion.

Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.

Assume SME leadership role within the Quality organization for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.

Represent Quality - Sterility Assurance on network teams (e.g., sterility assurance hub) and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.

Provide mentoring leadership to site SMEs to continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.

Build, maintain, and grow capability across the organization in the sterility assurance space. Prioritize knowledge development for the Q organization related to sterility assurance expertise (e.g., identify talent, define individual development plans, create education and training programs, coach, mentor). Participate in knowledge development beyond the Quality organization.

Provide technical support to new sites/filling lines during design and start-up activities to ensure sterility assurance programs and process/product requirements are supported at these sites, particularly while the sites are in early stages of building capability.

Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices/learnings/CAPAs across the parenteral sites.

Write internal standards and strategy documents related to sterility assurance and microbiological topics as required. Ensure that all Q decisions taken by the PQN related to sterility assurance and microbiological related topics are documented adequately, either in Lilly internal Quality standards or strategy documents, and they are traceable.

Benchmark industry trends and emerging regulatory guidance/requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly’s position on technical/regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.

Partner with the TSMS Sterility Assurance organization to oversee and administer the sterility assurance program

Engage in providing support during regulatory interactions such as RtQ of submissions and on-site inspections

Define and execute the process for sharing regulatory agency observations and commitments, including discussion on implementation impact evaluation across the PPN sites. Ensure there is a tracking system for decisions and for implementation completion at the sites.

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals

Basic Qualifications:

BS Degree required.

MS/PhD in a biological science preferred

10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles

10+ years' experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment

Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)

Additional Preferences:

Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities

Strong written and oral communication skills

Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology

Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance

Demonstrated experience influencing site and network leaders to advance technical agenda projects

Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.

Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance

Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space

Work with engineering and TSMS SME’s to support Lilly platforms to maximize the performance and minimize sterility assurance risks

Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.

Strong capability to influence personnel and management across the organization

Close interaction with quality to enable internal audits that identify risks

Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.

Additional Information:

Approximately 25% travel to connect with sites and CMOs, lead workshops across the network, participate in PPN meetings and trouble shooting

This position will predominantly support the US-based parenteral manufacturing sites

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