Katalyst CRO
Job Description
The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics, and combination products. This role ensures that all quality-related activities from raw material receipt through final product release are conducted in alignment with corporate quality policies, applicable regulatory requirements, and industry standards. The Manager, Quality Systems will support the organization's strategic quality objectives and convert those strategies into clear, actionable plans. Key areas of support may include Document Control, Device Quality Assurance, Labeling Compliance, Validation, Training, and Quality Intelligence. The role requires strong leadership in maintaining a robust and compliant Quality Management System (QMS) while driving continuous improvement.
Responsibilities
Provide quality assurance oversight for assigned manufacturing processes and product lines, ensuring compliance with corporate policies and regulatory requirements (FDA, ISO, GMP, etc.).
Translate quality strategy into tactical objectives to support operational and regulatory goals.
Oversee and support core Quality System functions such as Document Center operations, Device QA activities, Labeling review and approval, Validation documentation, Training program management, and Quality Intelligence reporting.
Ensure consistent application of quality processes from raw material inspection through finished goods release and shipment.
Develop, review, and approve Quality System procedures, work instructions, and process documentation.
Manage and support Supplier Controls, including supplier qualification, monitoring, audits, and corrective actions.
Collaborate cross-functionally to address quality issues, lead investigations, and implement effective CAPAs.
Maintain up-to-date knowledge of applicable regulatory changes and ensure timely integration into internal processes.
Support internal and external audits by regulatory bodies, customers, and corporate quality teams.
Requirements
Bachelor's degree in life sciences or related field.
Minimum of 8 years of experience in Quality Assurance, preferably within pharmaceutical or medical device manufacturing.
Strong knowledge of Quality Management Systems, regulatory standards, and industry best practices.
Demonstrated experience writing and managing Quality System procedures and process documents.
Experience with Supplier Controls and supplier quality management.
Excellent written and verbal communication skills, with ability to interact effectively across all organizational levels.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Business Consulting and Services
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Responsibilities
Provide quality assurance oversight for assigned manufacturing processes and product lines, ensuring compliance with corporate policies and regulatory requirements (FDA, ISO, GMP, etc.).
Translate quality strategy into tactical objectives to support operational and regulatory goals.
Oversee and support core Quality System functions such as Document Center operations, Device QA activities, Labeling review and approval, Validation documentation, Training program management, and Quality Intelligence reporting.
Ensure consistent application of quality processes from raw material inspection through finished goods release and shipment.
Develop, review, and approve Quality System procedures, work instructions, and process documentation.
Manage and support Supplier Controls, including supplier qualification, monitoring, audits, and corrective actions.
Collaborate cross-functionally to address quality issues, lead investigations, and implement effective CAPAs.
Maintain up-to-date knowledge of applicable regulatory changes and ensure timely integration into internal processes.
Support internal and external audits by regulatory bodies, customers, and corporate quality teams.
Requirements
Bachelor's degree in life sciences or related field.
Minimum of 8 years of experience in Quality Assurance, preferably within pharmaceutical or medical device manufacturing.
Strong knowledge of Quality Management Systems, regulatory standards, and industry best practices.
Demonstrated experience writing and managing Quality System procedures and process documents.
Experience with Supplier Controls and supplier quality management.
Excellent written and verbal communication skills, with ability to interact effectively across all organizational levels.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Business Consulting and Services
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