Quality Lead

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.

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.

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.

• 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…