Quality Lead - Validation & Compliance (Life Sciences)

PSC Biotech® Corporation; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

PSC Biotech® Corporation in Minneapolis seeks a Quality Lead to provide quality oversight for validation activities in a regulated life sciences environment. You will review protocols, reports, discrepancies, and supporting records to ensure compliance with GDP, cGMP, and company procedures.

Working with Validation, Engineering and Manufacturing, you will resolve issues, maintain inspection-ready documentation, and support audits.

Qualifications

• 7+ years QA, validation, or quality oversight experience in life sciences.
• Experience reviewing validation protocols, validation reports, discrepancies.
• Working knowledge of cGMP and regulated quality systems.
• Understanding of GDP and data integrity expectations.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Provide quality oversight and support for validation and qualification activities.
• Review validation protocols, reports, discrepancies, and associated documentation.
• Evaluate discrepancies, deviations, and unexpected results identified during validation execution and ensure appropriate resolution and documentation.
• Provide guidance to project teams regarding documentation practices, validation expectations, and GDP.
• Support inspection and audit readiness by ensuring validation records are complete, accurate, traceable, and maintained.
• Partner with Validation, Engineering, Manufacturing, and other cross-functional stakeholders to resolve documentation and compliance issues.

Skills

Quality leadership

Documentation review

GDP knowledge

cGMP knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

PSC Biotech® Corporation in Minneapolis seeks a Quality Lead to provide quality oversight for validation activities in a regulated life sciences environment. You will review protocols, reports, discrepancies, and supporting records to ensure compliance with GDP, cGMP, and company procedures.

Working with Validation, Engineering and Manufacturing, you will resolve issues, maintain inspection-ready documentation, and support audits.