Ensure controlled documents comply with company procedures and Good Documentation Practices (GDP).
Maintain document histories and ensure appropriate archival and retention of quality records.
Assist functional areas with development and revision of controlled documents.
Administer the Quality training program within the eQMS.
Assign and maintain training curricula based on employee roles and responsibilities.
Monitor training completion and follow up on overdue assignments.
Support onboarding and Quality/GxP training for new employees and contractors.
Support administration of the company change control program.
Support internal audits, supplier audits, and regulatory inspection readiness activities.
Assist with preparation and organization of documentation requested during audits and inspections.
Maintain Quality System records in an inspection-ready state.
Support Quality Agreement development and maintenance.
Promote compliance with applicable Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and data integrity requirements.
Support compliance with applicable FDA regulations and relevant global regulatory expectations.
Ensure electronic Quality records are complete, accurate, attributable, contemporaneous, and maintained in accordance with established procedures.
Support computerized system lifecycle and validation activities associated with Quality Systems.
Qualification, Education and Experience RequirementsBachelor’s degree in a scientific, engineering, life sciences, or related discipline is preferred. An equivalent combination of education and relevant pharmaceutical or biotechnology industry experience may be considered.
Minimum of 5 years of Quality Assurance (emphasis on Quality Systems) experience within the pharmaceutical, biotechnology, biologics, cell therapy, and/or gene therapy industry.
Demonstrated experience working within a regulated GxP Quality Management System.
Hands-on experience administering or extensively using an electronic Quality Management System (eQMS).
Experience with several Quality System processes, including document control, training, deviations, investigations, CAPA, supplier quality, and change control.
Experience in biologics, cell therapy, gene therapy, viral vector, or other advanced therapy manufacturing environments is highly desirable.
Working knowledge of applicable FDA cGMP requirements, including 21 CFR Parts 210 and 211.
Familiarity with relevant ICH guidance and contemporary pharmaceutical Quality System principles.
Understanding of Quality risk management, root cause analysis, CAPA, and change management principles.
Strong knowledge of Good Documentation Practices and data integrity expectations.
Ability to independently manage multiple Quality System records and priorities while meeting established timelines.
Strong attention to detail and ability to identify inconsistencies, compliance risks, and documentation deficiencies.
Strong written and verbal communication skills.
Ability to work effectively with technical and nontechnical personnel across multiple functions.
Ability to appropriately challenge Quality System documentation and decisions while maintaining collaborative working relationships.
Strong organizational, problem-solving, and analytical skills.
Experience with commonly used eQMS platforms such as Compliance Quest, Veeva Vault Quality, MasterControl, TrackWise Digital, or comparable systems is preferred.
Responsibilities
Role and Responsibilities Support the administration, maintenance, and continuous improvement of the company Quality Management System.
Serve as a key administrator and subject matter resource for the electronic Quality Management System (eQMS).
Support configuration, implementation, maintenance, and optimization of eQMS workflows and processes.
Monitor quality system activities to ensure records are initiated, investigated, reviewed, approved, and closed within established timelines.
Maintain Quality System metrics and identify trends, recurring issues, and opportunities for improvement.
Support periodic Quality Management Reviews and preparation of associated quality metrics and reports.
Manage controlled documents within the eQMS, including SOPs, policies, forms, templates, specifications, protocols, and reports.
Ensure controlled documents comply with company procedures and Good Documentation Practices (GDP).
Maintain document histories and ensure appropriate archival and retention of quality records.
Assist functional areas with development and revision of controlled documents.
Administer the Quality training program within the eQMS.
Assign and maintain training curricula based on employee roles and responsibilities.
Monitor training completion and follow up on overdue assignments.
Support onboarding and Quality/GxP training for new employees and contractors.
Support administration of the company change control program.
Support internal audits, supplier audits, and regulatory inspection readiness activities.
Assist with preparation and organization of documentation requested during audits and inspections.
Maintain Quality System records in an inspection-ready state.
Support Quality Agreement development and maintenance.
Promote compliance with applicable Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and data integrity requirements.
Support compliance with applicable FDA regulations and relevant global regulatory expectations.
Ensure electronic Quality records are complete, accurate, attributable, contemporaneous, and maintained in accordance with established procedures.
Support computerized system lifecycle and validation activities associated with Quality Systems.
Qualification, Education and Experience RequirementsBachelor’s degree in a scientific, engineering, life sciences, or related discipline is preferred. An equivalent combination of education and relevant pharmaceutical or biotechnology industry experience may be considered.
Minimum of 5 years of Quality Assurance (emphasis on Quality Systems) experience within the pharmaceutical, biotechnology, biologics, cell therapy, and/or gene therapy industry.
Demonstrated experience working within a regulated GxP Quality Management System.
Hands-on experience administering or extensively using an electronic Quality Management System (eQMS).
Experience with several Quality System processes, including document control, training, deviations, investigations, CAPA, supplier quality, and change control.
Experience in biologics, cell therapy, gene therapy, viral vector, or other advanced therapy manufacturing environments is highly desirable.
Working knowledge of applicable FDA cGMP requirements, including 21 CFR Parts 210 and 211.
Familiarity with relevant ICH guidance and contemporary pharmaceutical Quality System principles.
Understanding of Quality risk management, root cause analysis, CAPA, and change management principles.
Strong knowledge of Good Documentation Practices and data integrity expectations.
Ability to independently manage multiple Quality System records and priorities while meeting established timelines.
Strong attention to detail and ability to identify inconsistencies, compliance risks, and documentation deficiencies.
Strong written and verbal communication skills.
Ability to work effectively with technical and nontechnical personnel across multiple functions.
Ability to appropriately challenge Quality System documentation and decisions while maintaining collaborative working relationships.
Strong organizational, problem-solving, and analytical skills.
Experience with commonly used eQMS platforms such as Compliance Quest, Veeva Vault Quality, MasterControl, TrackWise Digital, or comparable systems is preferred.
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