QA Auditor
Full time, with travel

Travel: 20-30% Domestic Travel Required
Industry: Pharmaceuticals, Dietary Supplements, Nutraceuticals, Life Sciences, Animal Health

Salary range: $70-95k; may be negotiable based on experience, education, geo location and other factors.

We are seeking an experienced Quality Assurance Auditor to lead supplier qualification and external quality oversight activities across a complex FDA-regulated manufacturing environment. This role is ideal for a quality professional who began their career supporting manufacturing operations and has developed a deep understanding of production processes, risk assessment, investigations, and supplier quality management.

The successful candidate will serve as a key quality partner responsible for ensuring suppliers, contract manufacturers, laboratories, and external service providers meet company quality and compliance requirements. This individual must be capable of evaluating quality systems, assessing manufacturing risks, conducting audits, and making informed decisions regarding supplier qualification and ongoing oversight.

The ideal candidate can confidently walk a manufacturing floor, understand the impact of operational decisions on product quality and compliance, and identify potential risks before they become issues.

Role:
Manage and continuously improve the supplier qualification and supplier oversight program.

• Lead qualification, approval, and periodic evaluation of raw material suppliers, packaging suppliers, contract manufacturers (CMOs), contract laboratories, and external service providers.

• Conduct supplier risk assessments and determine appropriate qualification and monitoring strategies.

• Review supplier quality systems, quality agreements, audit reports, regulatory histories, and performance metrics.

• Evaluate supplier changes, deviations, investigations, CAPAs, and non-conformance trends to assess supplier performance and risk.

• Develop supplier quality metrics and drive supplier quality improvement initiatives.

• Partner with Procurement, Manufacturing, Regulatory Affairs, Technical Operations, and Quality teams to ensure supplier compliance.

• Manage vendor approval processes and maintain supplier qualification documentation.

• Oversee third-party audit firms conducting supplier assessments on behalf of the organization.

• Support regulatory inspections and quality management system activities related to supplier management.

Supplier Quality Manager

Travel: 20-30% Domestic Travel Required
Industry: Pharmaceuticals, Dietary Supplements, Nutraceuticals, Life Sciences, Animal Health

Position Summary

We are seeking an experienced Supplier Quality Manager to lead supplier qualification and external quality oversight activities across a complex FDA-regulated manufacturing environment. This role is ideal for a quality professional who began their career supporting manufacturing operations and has developed a deep understanding of production processes, risk assessment, investigations, and supplier quality management.

The successful candidate will serve as a key quality partner responsible for ensuring suppliers, contract manufacturers, laboratories, and external service providers meet company quality and compliance requirements. This individual must be capable of evaluating quality systems, assessing manufacturing risks, conducting audits, and making informed decisions regarding supplier qualification and ongoing oversight.

The ideal candidate can confidently walk a manufacturing floor, understand the impact of operational decisions on product quality and compliance, and identify potential risks before they become issues.

Key Responsibilities

Supplier Qualification & External Compliance (Approximately 70%)

• Manage and continuously improve the supplier qualification and supplier oversight program.

• Lead qualification, approval, and periodic evaluation of raw material suppliers, packaging suppliers, contract manufacturers (CMOs), contract laboratories, and external service providers.

• Conduct supplier risk assessments and determine appropriate qualification and monitoring strategies.

• Review supplier quality systems, quality agreements, audit reports, regulatory histories, and performance metrics.

• Evaluate supplier changes, deviations, investigations, CAPAs, and non-conformance trends to assess supplier performance and risk.

• Develop supplier quality metrics and drive supplier quality improvement initiatives.

• Partner with Procurement, Manufacturing, Regulatory Affairs, Technical Operations, and Quality teams to ensure supplier compliance.

• Manage vendor approval processes and maintain supplier qualification documentation.

• Oversee third-party audit firms conducting supplier assessments on behalf of the organization.

• Support regulatory inspections and quality management system activities related to supplier management.

Auditing & Quality Oversight (Approximately 30%)

• Plan, conduct, and document supplier audits in accordance with company procedures and regulatory requirements.

• Perform on-site and remote audits of:

  • Raw material suppliers

  • Packaging suppliers

  • Contract Manufacturing Organizations (CMOs)

  • Contract laboratories

  • Critical service providers

• Assess supplier quality systems for compliance with FDA regulations, GMP requirements, and applicable industry standards.

• Review audit findings and ensure effective corrective and preventive actions (CAPAs) are implemented.

• Monitor audit observations, supplier remediation plans, and overall supplier performance.

• Coordinate and oversee third-party auditors supporting the supplier audit program.

Required Qualifications

• Bachelor's degree in Quality, Life Sciences, Engineering, Chemistry, Microbiology, or related technical discipline.

• 5+ years of quality experience within an FDA-regulated manufacturing environment.

• Demonstrated experience supporting manufacturing quality operations before moving into supplier quality or supplier compliance roles.

• Strong working knowledge of:

  • Production processes

  • Deviations

  • Investigations

  • CAPAs

  • Non-conformances

  • Risk assessments

  • Supplier quality systems

• Experience qualifying and managing external suppliers in regulated manufacturing environments.

• Proven supplier auditing experience.

• Strong understanding of GMP regulations and quality system requirements.

• Ability to independently evaluate quality and compliance risks and make sound business decisions.

Preferred Experience

Candidates with experience in the following environments are strongly preferred:

• Pharmaceuticals

• Dietary Supplements

• Nutraceuticals

• Life Sciences

• Animal Health Manufacturing

Experience with complex manufacturing operations involving ingredient blending, formulation, process validation, and regulated production environments is highly valued.

Ideal Candidate Profile

The ideal candidate has hands-on experience in manufacturing quality and understands how quality decisions affect operations, compliance, and product safety. They can assess risk in real-time, ask the right questions during audits, and effectively evaluate supplier quality systems beyond documentation alone.

Strong candidates will have direct experience auditing and qualifying:

• Raw Material Suppliers (highest priority)

• Packaging Suppliers

• Contract Manufacturing Organizations (CMOs)

• Contract Laboratories

• Third-Party Audit Providers

Candidates whose experience has been limited primarily to laboratory quality, warehousing, distribution, or commercial quality functions may not possess the breadth of manufacturing and supplier oversight experience required for this role.

Travel Requirements

• 20-30% travel required.

• Primarily domestic travel.

• Frequent supplier locations include:

  • Utah

  • Kansas

  • Missouri

  • Wisconsin

• International supplier audits in Southeast Asia are generally performed by third-party auditors under this role's oversight.

• Travel is typically planned well in advance, with minimal short-notice requirements.

Strong preference for candidates with experience using:

• Qualityze

• TrackWise

• SAP

• Electronic Batch Record (EBR) systems

• Lens

• Supplier Management and Quality Management System (QMS) platforms

Experience helping to develop, optimize, or expand supplier management workflows within electronic quality systems is highly desirable.

Plan, conduct, and document supplier audits in accordance with company procedures and regulatory requirements.

• Perform on-site and remote audits of:

  • Raw material suppliers

  • Packaging suppliers

  • Contract Manufacturing Organizations (CMOs)

  • Contract laboratories

  • Critical service providers

• Assess supplier quality systems for compliance with FDA regulations, GMP requirements, and applicable industry standards.

• Review audit findings and ensure effective corrective and preventive actions (CAPAs) are implemented.

• Monitor audit observations, supplier remediation plans, and overall supplier performance.

• Coordinate and oversee third-party auditors supporting the supplier audit program.

Required:

• Bachelor's degree in Quality, Life Sciences, Engineering, Chemistry, Microbiology, or related technical discipline.

• 5+ years of quality experience within an FDA-regulated manufacturing environment.

• Demonstrated experience supporting manufacturing quality operations before moving into supplier quality or supplier compliance roles.

• Strong working knowledge of:

  • Production processes

  • Deviations

  • Investigations

  • CAPAs

  • Non-conformances

  • Risk assessments

  • Supplier quality systems

• Experience qualifying and managing external suppliers in regulated manufacturing environments.

• Proven supplier auditing experience.

• Strong understanding of GMP regulations and quality system requirements.

• Ability to independently evaluate quality and compliance risks and make sound business decisions.

Preferred Experience

Candidates with experience in the following environments are strongly preferred:

• Pharmaceuticals

• Dietary Supplements

• Nutraceuticals

• Life Sciences

• Animal Health Manufacturing

Experience with complex manufacturing operations involving ingredient blending, formulation, process validation, and regulated production environments is highly valued.

Ideal Candidate Profile

The ideal candidate has hands-on experience in manufacturing quality and understands how quality decisions affect operations, compliance, and product safety. They can assess risk in real-time, ask the right questions during audits, and effectively evaluate supplier quality systems beyond documentation alone.

Strong candidates will have direct experience auditing and qualifying:

• Raw Material Suppliers (highest priority)

• Packaging Suppliers

• Contract Manufacturing Organizations (CMOs)

• Contract Laboratories

• Third-Party Audit Providers

Candidates whose experience has been limited primarily to laboratory quality, warehousing, distribution, or commercial quality functions may not possess the breadth of manufacturing and supplier oversight experience required for this role.

Travel Requirements

• 20-30% travel required.

• Primarily domestic travel.

• Frequent supplier locations include:

  • Utah

  • Kansas

  • Missouri

  • Wisconsin

• International supplier audits in Southeast Asia are generally performed by third-party auditors under this role's oversight.

• Travel is typically planned well in advance, with minimal short-notice requirements.

Preferred Systems & Technology Experience

Strong preference for candidates with experience using:

• Qualityze

• TrackWise

• SAP

• Electronic Batch Record (EBR) systems

• Lens

• Supplier Management and Quality Management System (QMS) platforms

Experience helping to develop, optimize, or expand supplier management workflows within electronic quality systems is highly desirable.

Pay Details: $70,000.00 to $95,000.00 per hour

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.