Systems Manager - Quality

What You'll DoAs a key member of the Quality team, you will oversee core quality system processes including CAPA, change management, customer complaints, product release, internal auditing, document control, and regulatory readiness. You will play an important role in ensuring compliance with FDA regulations, customer requirements, and internal quality standards while helping drive continuous improvement across the facility.Quality Systems LeadershipDevelop and manage deviation, non-conformance, investigation, and CAPA processes.Lead and maintain the site's Change Management program.Oversee customer complaint management, including investigations, trend analysis, reporting, and corrective actions.Manage product release activities, batch record review processes, quality metrics, and customer Certificates of Analysis (CoAs).Coordinate Annual Product Reviews and Quarterly Management Reviews.Administer the Document Control program, including change control activities and system metrics.Lead the Internal Auditing program, including auditor training, audit execution, system development, and reporting.Regulatory Compliance & Continuous ImprovementPartner closely with Quality Operations, Quality Laboratory, and Manufacturing teams to ensure effective and compliant quality systems.Serve as a key participant during FDA inspections, customer audits, and third-party regulatory audits.Manage GMP and sanitation programs and improvement initiatives.Drive a culture of quality, compliance, and operational excellence throughout the organization.Team LeadershipDevelop, coach, and manage direct reports.Foster collaboration and accountability while supporting Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.What We're Looking ForRequired QualificationsBachelor's degree in Chemistry, Microbiology, Biology, Engineering, or a related scientific discipline.Minimum of seven years of experience supporting quality assurance systems within pharmaceutical, medical device, or other FDA-regulated manufacturing environments.Minimum of three years of leadership experience or experience serving in an advisory capacity.Five or more years of experience interacting with regulatory agencies or regulatory bodies, such as the FDA or TGA.Demonstrated experience with:Root cause analysisRisk analysis methodologiesCAPA managementRegulatory investigationsInternal and external auditsDocument control systemsChange managementComplaint managementDeviation and non-conformance programsPreferred QualificationsAdvanced degree in a scientific or related discipline.Why Join Rockline?Rockline Industries is a privately held manufacturer and distributor of consumer packaged goods with a long-standing reputation for innovation, quality, and customer partnership. Our associates help produce products used by millions of consumers every day.When you join Rockline, you'll find:A stable, privately held organization focused on long-term successOpportunities to make a meaningful impact in a highly regulated manufacturing environmentCross-functional collaboration with operations, quality, laboratory, and leadership teamsA culture built around our RRITE values: Renew, Respect, Integrity, Teamwork, and ExcellenceCareer growth and development opportunities within a global manufacturing organizationWith headquarters in Sheboygan, Wisconsin, Rockline employs more than 800 associates locally and thousands globally, supporting customers and consumers across North America and beyond.Benefits That Support YouWe offer a comprehensive benefits package designed to support your health, financial security, and work-life balance, including:Health & Wellness:Medical, dental, and vision coverageWellness programsFitness reimbursementFinancial SecurityRetirement savings plan with company matchLife and disability insuranceOptional supplemental coverageCareer & LifestylePaid time off starting on your first dayEducation reimbursementEmployee discount programsMental Health SupportConfidential counseling and resources for personal and work-life needsJob SummaryRequisition Number: SYSTE007323Job Category: Quarterly Check-in (Manager with Qtrly DRs)Schedule: Full-Time