Senior Quality Leader, Sterile Pharma Operations

Par Health Enterprises LLC; Rochester (MI); On-site; USD 120,000 - 170,000; Full time

Job summary

Par Health seeks a Principal Quality Specialist, Operations to provide QA oversight in a sterile pharmaceutical manufacturing environment. You will lead defect characterization, risk assessments, and investigations while ensuring compliance with cGMP and regulatory standards across Operations and Quality teams.

You will collaborate with Engineering, Technical Services, and Compliance to drive continuous improvement, manage quality systems, and support investigations and CAPAs in a fast-paced

Qualifications

• Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related technical discipline.
• Minimum of 9 years of experience in pharmaceutical/biotech/regulated manufacturing environments.
• Experience supporting Quality Assurance, Manufacturing Quality Assurance, Quality Systems, or Quality Control activities.

Responsibilities

• Provide quality assurance oversight during manufacturing operations, including inspections, line clearances, and product releases.
• Offer real-time quality guidance to manufacturing personnel and ensure compliance with cGMP, GDP, SOPs and regulatory requirements.
• Review and approve production documentation, batch records, logbooks, and related quality records for completeness and accuracy.
• Evaluate defects and assess potential product impact; classify defects and support investigations and CAPAs.
• Lead or support investigations involving product defects, contaminations, deviations, and regulatory inspections.
• Identify opportunities to improve product quality, inspection processes, and quality systems.

Skills

Quality Assurance

Regulatory Compliance

cGMP

Sterile Manufacturing

Quality Systems

Defect Characterization

Risk Assessment

Investigations

Education

Bachelor's degree in Science, Biology, Chemistry, Microbiology, Engineering, Quality, or related technical discipline

Tools

ERP systems

Microsoft Office

Job description

Par Health seeks a Principal Quality Specialist, Operations to provide QA oversight in a sterile pharmaceutical manufacturing environment. You will lead defect characterization, risk assessments, and investigations while ensuring compliance with cGMP and regulatory standards across Operations and Quality teams.

You will collaborate with Engineering, Technical Services, and Compliance to drive continuous improvement, manage quality systems, and support investigations and CAPAs in a fast-paced