Sr. QA Manager

JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge tothousands of biopharma companies and their patients. We are PCI. Ourinvestment is in People who make an impact, drive progress and create abetter tomorrow. Our strategy includes building teams across our globalnetwork to pioneer and shape the future of PCI. The Senior QA Managerwill work with other departments to ensure the quality of products andcompliance to internal procedures and external standards. The rolesupports and provides quality oversight of the day-to-day operations ofthe Madison, WI based drug manufacturing facility. In this role, theopportunity exists for the incumbent to shape and transform GxP programsby providing QA expertise and guidance to lead product candidates andpipeline assets. The incumbent will also be a key member of a crossfunctional team focused on harmonization and improvement of qualitysystems and processes across all PCI WI GMP locations. Essential Dutiesand Responsibilities: To perform this job successfully, an individualmust be able to perform each essential duty satisfactorily. Theessential duties and responsibilities include the following but otherduties may be assigned. Provides quality oversight of manufacturingactivities on a day-to-day basis. Review, develop, and improve qualitysystem procedures, specifications, and test methods. Provide statusreports, including relevant quality metrics and participates in themanagement review process. Establish collaborative relationships withinternal and external customers to ensure all quality and compliancematters and any issues that arise are addressed in an open and timelymanner. Monitor, identify, and propose quality process/systemimprovements and provides strategic foresight to identify and implementchanges to enhance long term goals of the department and drivecontinuous improvement. Serve as QA representative to cross functionalproject teams such as process improvement. Perform risk assessments tocomply with internal procedures and external guidelines. Initiate,revise, and review controlled cGMP documents including SOPs, MaterialSpecifications, Investigation protocols/reports, validationprotocols/reports as applicable. Ensures site readiness for regulatoryinspections, client audits, and internal audits. Perform review of rawmaterial documentation for release of internal and external clinicalproducts/commercial products, while ensuring compliance with cGMPs,site... For full info follow application link. LSNE is an EEO/AAEmployer and all qualified applicants will receive consideration foremployment without regard to, their race, color, religion, sex, age,national origin, ancestry, sexual orientation, gender identity,disability, protected genetic information, protected veteran status,military service, or other protected status. The Company's EEO policy,as well as its affirmative action obligations, include the full andcomplete support of The Company. APPLICATION INSTRUCTIONS:Apply Online: ipc.us/t/A5821F7AFEC74D1A

Created: 2025-11-15