Quality Lead

PSC Biotech® Corporation; Minneapolis (MN); Presencial; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Quality leadership

Documentation review

GDP knowledge

cGMP knowledge

Cross-functional collaboration

Communication skills

Formação académica

Bachelor's degree in Engineering or Life Sciences

Descrição da oferta de emprego

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

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

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.