Carex is partnering with a biopharmaceutical industry partner to hire a Manager of Quality Engineering to lead commissioning, qualification, and validation (CQV) quality activities supporting GMP manufacturing and GLP/GMP testing. This role will provide quality oversight across the process lifecycle—from equipment and facility validation to process development and annual drug product reviews. The ideal candidate will drive procedural development, ensure compliance with industry standards, and collaborate cross-functionally within a highly regulated environment.
This is an on-site role in Madison, WI. Our partner is open to supporting relocation to the area.
What You’ll Do
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Prepare, update, and review procedural documents including SOPs, policies, work instructions, forms, protocols, and test methods using established templates.
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Collaborate with departments such as Manufacturing, Engineering, Analytical Development, QC, and Facilities to gather information for equipment installation and maintenance planning.
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Work with system owners and users to define validation requirements and intended use.
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Review and approve validation documentation including master plans, protocols, user requirements, impact assessments, and final reports.
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Manage document lifecycle through electronic systems such as Veeva QualityDocs and Arrowhead’s EDMS.
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Initiate, review, and approve change controls related to equipment and facility updates.
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Maintain tracking systems (e.g., Blue Mountain Regulatory Asset Manager) for equipment and instrument data.
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Provide Quality support for the metrology program, including calibration scheduling, vendor coordination, and data review.
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Support cleaning verification and validation activities for facilities and equipment.
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Evaluate and track deviations and CAPAs related to CQV and metrology operations.
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Develop and oversee procedures for periodic CQV reevaluation and re-execution for instruments, equipment, and facilities.
What You’ll Bring
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Bachelor’s degree in a scientific field.
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8+ years of quality or validation experience within pharmaceutical, biotech, contract manufacturing, or contract research environments.
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3+ years of hands-on CQV experience in a commercial GMP manufacturing setting.
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Working knowledge of GMP and/or GLP regulatory requirements.
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Strong documentation skills and experience with validation activities and quality systems.
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Experience leading or contributing to quality system documentation and improvements.
Preferred Qualifications
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Advanced degree in a related field.
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Quality certifications such as CQA or CQMP.
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Experience with electronic document management systems in regulated environments.
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.
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