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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.
Responsibilities
Drug Product External Manufacturing (DPEM) Sterility Assurance/Micro Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to Contract Manufacturers (CMs) and other DPEM members for parenteral quality assurance activities. Secondary loop is responsible for improving technical capabilities, supporting operational control strategy, resolution of the most critical/complex deviations and leading complex projects.
This role provides guidance to primary loop with respect to daily micro and sterility assurance activities and provides oversight of these activities in support of the DPEM QA Team, to ensure they are executed in accordance with company quality policies and procedures and comply with current Good Manufacturing Practice (cGMP) guidelines and regulations.
Key Objectives/Deliverables:
Oversight of Parenteral Quality Management System and operations:
Subject Matter Expert and Technical Mentor for Production and microbiology Sterility Assurance quality system elements. Provide feedback, coaching, mentoring to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to sterility assurance and micro topics.
Acting as a subject matter expert for sterility assurance and microbiology, operates cross-functionally to develop approaches and to drive harmonization of practices in the DPEM.
Through liaison with DPEM QA Managers, TS/MS and Quality staff, monitors the performance at contract manufacturers and identify concerns as relevant. Escalate concerns in a timely manner with recommendations.
Provide support for Inspections/Audits (observation and answers), lead inspection readiness assessments to support regulatory inspections of CM’s.
Ensure training in relation with Parenteral Processes and Sterility Assurance within DPEM and CMs upon request.
Responsible for Sterility Assurance review at CM.
Ensure continuous regulatory and technology oversight.
Assess capabilities of existing CMs to produce additional products, particularly with regard to quality topics (segregation, sterility assurance, cleaning validation, skills of the staff, procedures, training, etc).
Develop internal network contacts (TS/MS and QA) for supporting investigations, keeping aware of emerging topics in Lilly and understanding the impact on Contract Manufacturing oversight.
Develop strategies for ensuring that Contract Manufacturers are aware of emerging industry trends and influencing their plans for meeting the standards.
Improve DPEM technical capabilities by providing guidance to primary loop representatives.
Define the appropriate quality/technical standards for CMs, especially relating to parenteral quality assurance aspects and cooperate when appropriate with internal experts in the preparation of Lilly standards.
Review new and revised global standards.
Complete related assessments and determine impact on DPEM processes and procedures. Work with DPEM management and Quality Systems owners to develop and create appropriate action plan to ensure alignment with required standards.
Participate in the creation and review of local procedures related to sterility assurance activities.
Determine training needs for DPEM team members as appropriate.
Prepare and present management review at Site Quality Lead Team (SQLT) at least once a year in accordance with global standards changes and assessment.
Track and monitor sterility assurance/micro metrics looking for potential trends across different EMs manufacturing the same product or using same technologies.
Contract Manufacturing support (as required):
Provide support to primary loop for significant deviations, change controls, adverse microbiological data trends, CAPA identification, validation and qualification dossiers, technical report writing, as needed.
Help and give the CM guidance on resolution of technical /quality issues, in conjunction with “Technical Services / Manufacturing Science” (TSMS).
Review/approve major deviations and change controls, technical reports, and any other technical document, as needed.
Lead critical/complex deviations (as required).
Provide guidance to DPEM team members to monitor compliance and operational performance at contract manufacturers and establish robust action plans for inclusion on quality plans to remediate gaps.
Follow-up on Corporate Quality Assurance (GQA – Auditing & compliance, GQAAC) audit findings, ensuring that the CM is taking appropriate action in the due time.
Keep DPEM management informed of issues / progress, including internal notification to management of quality issues, when required.
Provide input to monthly reports to senior management.
As required, participate in performance reviews i.e. dashboard, APR, OPV, profile and portfolio review.
Provide quality support for new products / new implementation of new CMs.
Participate in due diligence assessments of prospective new external partners, as required. Assess new CMs, particularly with regard to their level of implementation of Lilly standards and recommend their suitability as a future partner.
Define, in conjunction with TSMS, the qualification protocols prior to the start of manufacturing operations.
Define, in conjunction with TSMS, the validation protocols, and approve them prior to the start of manufacturing operations.
Facilitates communications between QA Leads/EMs and global GQS SMEs relating to CM parenteral quality related activities.
Continuous Improvement:
Provide technical leadership and project management oversight to drive improvement to DPEM and CM Sterility Assurance Quality system.
Support EMs efforts to maintain and improve their quality systems.
Participate on Lean initiatives to help improve productivity.
Basic Qualifications
Bachelor`s Degree in Microbiology, Pharmacy, Chemistry, or equivalent experience.
Microbiology background.
Significant experience in technical and quality functions within a parenteral manufacturing plant, ideally both in parenteral products and dry products.
Additional Skills/ Preferences
Technical understanding of GMPs and the Global Quality Standards.
Strong written and communication skills, especially attention to detail.
Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
Ability to organize, prioritize, multi-task and influence others.
Strong decision making and problem-solving skills.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Willingness to travel.
Appreciation for cultural diversity.
Established technical, quality, and internal/external networks.
Experience with Lilly systems (Trackwise, QDocs…etc).
Understanding of micro/sterility testing.
Strong Coaching/Mentoring skills.
Additional Information
Shift is days, but off hours may be necessary to support operations. Expectation to be onsite at Lilly Corporate Center 4 days per week when not traveling.
Travel is possible, up to 30 %.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
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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