Senior Validation Quality Lead

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

Benefits offered by this job

Medical premiums

Dental & Vision

401(k)

PTO

Education Assistance

Pet Insurance

Fitness benefits

Discounts

Job summary

PSC Biotech® Corporation in Minneapolis seeks an experienced 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 activities are executed in accordance with approved procedures and GDP.

This role partners with Validation, Engineering, Manufacturing and cross‑functional teams to drive compliant execution, resolve quality issues, and maintain inspection‑ready

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or related discipline.
• 7+ years QA/validation experience in pharma or regulated life sciences.
• Experience reviewing validation protocols, reports, deviations, and supporting docs.
• Working knowledge of cGMP and regulated quality systems.
• Understanding validation/qualification for equipment, facilities, utilities, processes.
• Experience supporting deviation investigations.
• GDP and data integrity expectations.
• Ability to independently review technical docs and identify concerns.
• Strong written and verbal communication across QA, Validation, Manufacturing.

Responsibilities

• Provide Quality oversight and support for validation and qualification activities.
• Review and approve validation protocols, reports, discrepancies, and associated documentation for accuracy, completeness, and compliance.
• Review validation documentation related to equipment, systems, facilities, utilities, and/or processes, as applicable.
• Evaluate discrepancies, deviations, and unexpected results identified during validation execution and ensure appropriate resolution and documentation.
• Provide Quality input on investigations, corrective actions, and documentation updates arising from validation activities.
• Ensure validation documentation aligns with approved procedures, quality systems, and applicable regulatory expectations.
• Partner with Validation, Engineering, Manufacturing, and other cross‑functional stakeholders to resolve documentation and compliance issues.
• Identify potential quality or compliance risks and communicate concerns to appropriate project stakeholders.
• Support timely review and approval of documentation to maintain project schedules while ensuring quality standards are met.
• Provide guidance to project teams regarding documentation practices, validation expectations, and Good Documentation Practices (GDP).
• Support inspection and audit readiness by ensuring validation records are complete, accurate, traceable, and appropriately maintained.
• Assist with continuous improvement initiatives related to validation and quality processes.

Skills

Quality leadership

Validation oversight

Documentation review

cGMP knowledge

GDP & data integrity

Cross-functional collaboration

Problem solving

Communication skills

Education

Bachelor’s degree in Engineering/Life Sciences

Job description

PSC Biotech® Corporation in Minneapolis seeks an experienced 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 activities are executed in accordance with approved procedures and GDP.

This role partners with Validation, Engineering, Manufacturing and cross‑functional teams to drive compliant execution, resolve quality issues, and maintain inspection‑ready