Systems Manager - Quality

Rockline Industries & Iatric Manufacturing•Sheboygan, WI

12d•Onsite

About The Position

As 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.

Requirements

Bachelor'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 analysis
Risk analysis methodologies
CAPA management
Regulatory investigations
Internal and external audits
Document control systems
Change management
Complaint management
Deviation and non-conformance programs

Nice To Haves

Advanced degree in a scientific or related discipline.

Responsibilities

Develop 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.
Partner 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.
Develop, coach, and manage direct reports.
Foster collaboration and accountability while supporting Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.