Job DescriptionYour RoleThe 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#LI-JL1
