Quality & Compliance Manager

Omya International AG

• $88K — $105K *
Superior, WI 54880In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Quality, Engineering, Chemistry, Food Science, Environmental Science, or a related field.
  • 7+ years of experience in quality, regulatory, food safety, or similar environments.
  • 3+ years of leadership experience in quality or compliance functions.
  • Experience leading audits and regulatory compliance activities.
  • Strong knowledge of Quality Management Systems (QMS) and regulatory compliance programs.

Responsibilities

  • Lead and maintain the site’s Quality Management System (QMS).
  • Ensure compliance with FDA, GMP, and ISO standards.
  • Develop and implement quality procedures and compliance programs.
  • Conduct customer and regulatory audits; maintain audit readiness.
  • Oversee environmental compliance programs and documentation.
  • Lead investigations into customer quality issues and coordinate resolutions.
  • Manage laboratory operations and foster team collaboration.

Benefits

  • Opportunity for professional growth in a well-regarded company.
  • Engagement in continuous improvement initiatives.
  • Supportive team environment emphasizing safety and compliance.
  • Leadership role influencing company-wide quality standards.
Full Job Description
BASIC FUNCTION:

Omya is seeking a Quality & Compliance Manager to lead the site's quality, food safety, regulatory compliance, environmental compliance, and laboratory functions. This role ensures products, processes, and management systems meet customer, regulatory, and company requirements while driving continuous improvement and operational excellence.


RESPONSIBILITIES:

Quality & Compliance

  • Lead and maintain the site's Quality Management System (QMS).
  • Ensure compliance with FDA, GMP, HACCP, FSSC 22000, ISO, and customer requirements.
  • Develop and maintain quality procedures, standards, and compliance programs.
  • Monitor quality performance and drive corrective and preventive actions (CAPA).
  • Lead root cause investigations, deviations, and continuous improvement initiatives.
    ​

Audits & Regulatory Management

  • Lead customer, regulatory, certification, and internal audits.
  • Maintain audit readiness and ensure records remain accurate and compliant.

Customer & Product Compliance

  • Respond to customer quality inquiries, complaints, and documentation requests.
  • Lead investigations and resolution of customer quality issues.
  • Support customer qualification programs, quality agreements, and compliance commitments.
  • Ensure customer specifications are effectively incorporated into site quality systems.

Environmental & HSE Compliance

  • Oversee environmental permits, compliance programs, testing, and reporting requirements.
  • Maintain compliance-related documentation, permits, procedures, and training records in an audit-ready state.
  • Support inspections, compliance reviews, and investigations involving environmental and HSE matters.
  • Partner with site leadership to strengthen compliance performance and reduce operational risk.
  • Promote a culture where health, safety, and environmental stewardship are shared responsibilities across all departments.

Laboratory & Team Leadership

  • Lead laboratory operations, testing programs, and equipment calibration activities.
  • Review analytical results, quality trends, and technical investigations.
  • Coach, develop, and lead the Quality & Compliance team.
  • Manage departmental objectives, resources, and budgets.
  • Foster a culture of accountability, collaboration, and continuous improvement.
  • Coordinate audit preparation, corrective actions, and follow-up activities.
  • Serve as the site's primary contact during inspections and regulatory reviews.

QUALIFICATIONS:

Education

  • Bachelor's degree in Quality, Engineering, Chemistry, Food Science, Environmental Science, or a related technical field.
  • Equivalent combinations of education and experience may be considered.

Experience

  • 7+ years of experience in quality, regulatory, food safety, environmental, laboratory, or manufacturing environments.
  • 3+ years of leadership experience in quality, laboratory, or compliance functions.
  • Experience leading audits, CAPA programs, investigations, and regulatory compliance activities.
  • Experience in GMP, HACCP, FDA, FSSC 22000, ISO, or similar regulated industries preferred.

Skills & Knowledge

  • Strong knowledge of Quality Management Systems (QMS) and regulatory compliance programs.
  • Experience with CAPA, Root Cause Analysis, Change Management, and continuous improvement tools.
  • Strong leadership, communication, project management, and problem-solving skills.
  • Ability to influence cross-functional teams and drive accountability.

Preferred Qualifications

  • HACCP Certification.
  • Lead Auditor Certification (ISO 9001, FSSC 22000, or equivalent).
  • Lean, Six Sigma, or Continuous Improvement certification.

* Ladders Estimates

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