Quality Manager — CGMP, ISO & Regulatory Leader

Aurorium; Midlothian (TX); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

401(k)

Disability Insurance

FSA/HSA

Paid Time Off

Paid Holidays

Job summary

Aurorium is seeking a Quality Manager to lead QA and QC activities on-site, ensuring a robust quality management system aligned with ISO 9001, SQF, and GMP standards. You will manage investigations into quality issues, drive continuous improvement, and maintain compliance across regulatory and customer requirements.

Responsibilities include developing and maintaining the Quality Management System, approving procedures, coordinating with Regulatory Affairs, and leading training and audit programs

Qualifications

• BS degree in Chemistry or Engineering; MS preferred.
• Internal auditor training.
• Proficiency in ISO 9001 and CGMP.
• ASQ certification (CQE, CQA or CMQ/OE) preferred.
• Lean and/or Six Sigma certification preferred.
• 7+ years’ experience in a CGMP environment – Food, API, Excipient or Pharmaceutical manufacturing.
• 3+ years’ experience in a supervisory/lead role.
• Hands-on experience in an analytical chemistry lab.

Responsibilities

• Oversee the development and maintenance of the on-site Quality Management System.
• Decision-making authority at site level regarding material and product quality.
• Approve all plant procedures affecting product quality.
• Collaborate with Regulatory Affairs on regulatory aspects; registrations, licenses, DMFs, CEPs, method validation.
• Maintain SQF certification; manage Change, out-of-spec, deviations and CAPA programs.
• Coordinate CGMP training; ensure compliance across the site.
• Audit site operations against SOPs; write audit reports and corrective actions.
• Lead investigations of customer complaints and supplier quality activities.
• Manage quality department budget and QA/QC staffing.
• Maintain Quality Agreements with suppliers and customers.
• Perform other duties as assigned.

Skills

Leadership

Time management

Problem solving

Communication

Auditing

Education

BS degree in Chemistry or Engineering (MS preferred)

Internal auditor training

ISO 9001 and CGMP proficiency

ASQ CQE/CQA/CMQ/OE preferred

Lean/Six Sigma certification preferred

Tools

SAP experience

Job description

Aurorium is seeking a Quality Manager to lead QA and QC activities on-site, ensuring a robust quality management system aligned with ISO 9001, SQF, and GMP standards. You will manage investigations into quality issues, drive continuous improvement, and maintain compliance across regulatory and customer requirements.

Responsibilities include developing and maintaining the Quality Management System, approving procedures, coordinating with Regulatory Affairs, and leading training and audit programs