Nature and Scope
The Quality Assurance Manager, External Manufacturing will be primarily responsible for supporting GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. This position will act as the lead Quality point of contact for assigned projects. Primary responsibilities of this position include support for all aspects of pharmaceutical lifecycle management including process development, commercial manufacturing and testing/release of drug product. Activities include working directly with Contract Manufacturing Organizations (CMO), change management, validation, batch dispositions, investigations, APR completion and supplier change decisions.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
· Responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, Quality Agreements, regulatory standards and the American Regent Quality Management System.
· Ensure high performance of third-party finished product contract manufacturers by establishing Quality KPI scorecard with regard to compliance and performance metrics.
· Drives timely decisions and facilitates active communication and information flow between contract manufacturer and American Regent functional teams.
· Ensure Quality and Compliance related matters meet appropriate GMP and regulatory requirements to ensure product is safe, pure, and effective.
· Supports American Regent Supply Chain Operations related to commercial product distribution and timely launch of new products by:
Serving as the Quality lead for technical transfer activities at external manufacturing partners.
Supporting manufacturing activities related to regulatory filings (i.e., on-site presence for engineering, validation, registration batch manufacturing, timely review, and approval of documents, etc.)
Facilitating approval or release of commercial product based on conformance to specifications, current Good Manufacturing Practices (cGMP's) requirements and /or contractual agreements.
· Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action.
· Investigating and determining the need for and managing any field alerts or recalls/withdrawals of company products manufactured by third party contract manufacturers.
· Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation.
· Performing on-site visits during manufacturing/packaging of American Regent products and create quality business review process.
· Initiate and attend periodic meetings with CMO as ARI QA representative.
· Make quality decision on CMO/Suppliers related tasks and events.
· Provide status update on CMP related tasks and action items to multiple internal departments.
· Monitor/track the relationship between ARI batches to CMO batches.
· Provide information and documentation needed for shipping products between ARI and CMOs.
· Monitor/track/trend batch disposition from CMOs. Create CMO related tasks tracking documents, update on time and share with multiple departments.
· Review and approve CMO/Suppliers executed batch records and batch disposition documents.
· Create and provide various CMO requested…