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.
The purpose of the Principal Associate - GMP Quality is to oversee all quality related matters of the LCCP Pharmacy. As the quality leader, this individual will be required to manage the Quality Management System (QMS) for the LCCP Pharmacy and ensure that quality requirements are built into business processes in the Pharmacy. This individual is the main point of contact between LCCP and other Good Manufacturing Practices (GMP) quality functions within Lilly.
Qualification and Maintenance of the LCCP Pharmacy
Be the quality expert in the qualification of the LCCP Pharmacy.Ensure the maintenance of the LCCP pharmacy is in accordance with local regulations and requirements.Oversee quality aspects of activities related to the qualification and maintenance of the LCCP pharmacy, which can include Commissioning and Qualification of GMP assets and review and approval of associated documentation.Manage the Pharmacy Quality Management System
Accountable for the creation and effective implementation of quality management in the LCCP pharmacy.Ensure local implementation of global policies and procedures in business practices in the LCCP pharmacy.Oversee service providers and vendors and ensure appropriate agreements (e.g. Quality Agreements) are in place.Have quality oversight of the LCCP pharmacy GMP activities, which may include: Facility, Utilities, HVAC, and Equipment (FUME) to ensure compliance with quality systems. Maintenance/Calibration programs, including review and approval of work performed by GMP Service Providers. Contamination Control strategy, including the Environmental Monitoring and Cleaning programs.Performs batch disposition for Extemporaneous Preparation products manufactured at the LCCP Pharmacy.Create and maintain the LCCP Quality Manual and ensure LCCP Pharmacy compliance to the requirements of the Quality Manual.Ensure implementation of appropriate change control systems and deviation/non-compliance reporting.Escalate/Notification to Management for departure of critical nature and assure issues are addressed appropriately.Identify opportunities for and participate in continuous improvement.Collate and report quality metrics for LCCP Pharmacy performance for quality governance meetings.Inspections and Audits
Hosts and facilitates inspections and audits for the LCCP Pharmacy.Lead inspection and audit preparation activities.Coordinate responses to inspections and audits.Ensures that appropriate CAPA is put in place for inspections/audits and tracks completion of commitments.Conduct shared learning sessions from inspections/audits.Perform internal quality self-assessments and inspections.Ensure activities in the LCCP pharmacy are in compliance with local regulations and cGMP requirements.Partnership With Other Area(s)
Collaborates with other quality groups as appropriate and develop quality network.Serve as Business Quality Assurance (BQA) representative for IT systems, as assigned.Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.Review and approve as appropriate, documents associated with the development and maintenance of IT systems.Partner with IT and the business on system-related initiatives/changes as the BQA for assigned IT systems.Participate in and conduct audits according to GQAAC’s requirements as part of the Guest Auditor role.Participate in and conduct site visits as part of the Person-In-Plant (PIP) monitoring activity with PR&D.REQUIRED QUALIFICATIONS, SKILLS AND EXPERIENCE
Bachelor’s or Master’s Degree in a science or health care related field, or engineering.Five years experience working in a GMP environment.At least 3 years experience working as a Quality person in a GMP environment.Knowledgeable of cGMP regulations and GMP Quality Systems.Able to communicate effectively, both written and verbal and to influence others.Able to prioritize and handle multiple concurrent tasks.Able to apply risk-based decision making in a regulated environment and apply phase-appropriate GMP standards.Able to work independently when required.OTHER INFORMATION
Occasional Travel may be required (less than 10%) for training, conferences, etc.Able to attend/participate/lead meetings (via teleconferences) after official office hours.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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly