Systems Manager - Quality

Rockline Industries, people who make it right

Sheboygan (WI)

On-site

USD 120,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Wellness programs

Retirement plan

Life insurance

Paid time off

Education reimbursement

Employee discounts

Mental health support

Job summary

Rockline Industries, headquartered in Sheboygan, Wisconsin, seeks a seasoned Quality Systems Leader to oversee CAPA, change management, customer complaints, product release, audits, and document control to ensure FDA regulatory readiness.

The role emphasizes driving continuous improvement, leading a team, and coordinating annual product reviews alongside cross-functional stakeholders to uphold Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.

Qualifications

Bachelor's degree in a scientific discipline required.
Minimum 7 years supporting QA systems in FDA-regulated environments.
Minimum 3 years in a leadership or advisory role.
5+ years interacting with regulatory agencies such as FDA or TGA.

Responsibilities

Oversee CAPA, change management, and complaint management within the quality system.
Manage product release, batch review, and CoA processes; track quality metrics.
Coordinate annual product reviews and quarterly management reviews.
Lead the internal auditing program including training, execution, and reporting.
Drive regulatory readiness and ensure GMP compliance across the facility.

Skills

Root cause analysis

Risk analysis

CAPA management

Regulatory investigations

Internal audits

Document control

Change management

Complaint handling

Deviation handling

Non-conformance control

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or related

Job description

What You'll Do

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.

Quality Systems Leadership

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.

Regulatory Compliance & Continuous Improvement

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.

Team Leadership

Develop, 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 For

Required Qualifications

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

Preferred Qualifications

Advanced 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 success
Opportunities to make a meaningful impact in a highly regulated manufacturing environment
Cross-functional collaboration with operations, quality, laboratory, and leadership teams
A culture built around our RRITE values: Renew, Respect, Integrity, Teamwork, and Excellence
Career growth and development opportunities within a global manufacturing organization

With 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 You

Health & Wellness