Manager, Quality Assurance

The Manager of Quality is responsible for supporting manufacturing, clinical and preclinical operations. This individual will be responsible for conducting audits of third parties, participating in the maintenance of a phase appropriate quality system, and the review of quality system and technical documentation.

Requirements

• Plan, conduct and close out audits for third parties (e.g. CMO, CRO, and service providers) and maintain an approved vendor list
• Conduct internal GxP audits
• Maintain the quality management system to ensure adherence to applicable global regulatory requirements.
• Conduct batch record review (Executed and Master) for all phases of manufacturing (drug substance, drug product, packaging, labeling, and associated intermediates)
• Provide final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)
• Author and review internal and third party deviations, CAPAs, and change controls
• Investigation of product complaints
• Review and approval of analytical and manufacturing documentation including analytical methods; analytical qualification protocol/reports; stability protocols/reports; and specifications
• QC of IMPD/IND CMC sections, as well as, clinical study documents such as protocols, IBs, etc
• Review of CRO preclinical and clinical study documentation
• Review and approval of clinical product labels
• Authoring, revising and reviewing SOPs to ensure compliance with regulatory requirements
• Implementation of process improvements
• Ensuring that GMP work at contract manufacturing organizations, GLP/GCP work at sites/CROs is done in compliance with applicable laws, regulations, guidelines, and SOPs.