Quality Validation 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

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

The Quality Lead provides quality oversight and leadership for validation activities within a regulated life sciences environment. This role is responsible for reviewing and approving validation documentation, including protocols, reports, discrepancies, and supporting records, to ensure activities are executed in accordance with approved procedures and applicable quality requirements. The Quality Lead partners closely with Validation, Engineering, Manufacturing, and other cross-functional teams to facilitate compliant execution, resolve quality issues, and maintain inspection‑ready documentation.

• 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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline.
• 7+ years Quality Assurance, validation, or quality oversight experience within the pharmaceutical, biotechnology, or other regulated life sciences industry.
• Experience reviewing validation protocols, validation reports, discrepancies, deviations, and supporting documentation.
• Working knowledge of current Good Manufacturing Practices (cGMP) and regulated quality systems.
• Understanding of validation and qualification principles for equipment, facilities, utilities, systems, and/or manufacturing processes.
• Experience supporting discrepancy or deviation resolution and associated investigations.
• Strong understanding of Good Documentation Practices (GDP) and data integrity expectations.
• Ability to independently review technical documentation and identify quality, compliance, or documentation concerns.
• Strong written and verbal communication skills with the ability to collaborate effectively across Quality, Validation, Engineering, and Manufacturing teams.
• Strong organizational and prioritization skills with the ability to manage multiple documentation reviews and project priorities.
• Must be authorized to work in the U.S.
• No C2C at this time.

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
• Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer‑sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.