Norma Santana Email & Phone Number

Boston, MA, US

Carlsbad, CA, US

• Manages and maintains a comprehensive risk-based GCP/GLP/GVP compliant quality audit program.
• Develops and manages audit schedule, budgetary, and resource needs for all audit types.
• Manages relationships with QA service providers, including but not limited to: consultant auditors, quality consultants, translation vendors, etc.
• Establishes and and/or leads vendor QA-QA relationships with preferred/critical CROs and vendors, including implementation of quality agreements, as applicable.
• Manages vendor risk assessments.
• Establishes and maintains QA metrics and/or dashboards to support Quality oversight.

Lexington, Massachusetts, US

Oversight and ownership of the Supplier Quality Management (SQM) programs which encompass the quality input/aspects of the Supplier selection, Quality Technical Agreements, Supplier communications, Supplier Auditing program, Supplier Qualification, Supplier KPIs, Material Lifecycle program and related elements.

Lexington, Massachusetts, US

Responsible for the management and administration of all GxP Documentation and Training systems and their related processes. Also responsible for maintaining the tracking systems that govern the supplier quality program.

Cambridge, Massachusetts, US

• Overview: Develop and implement processes to support Document Management and Records Management functions in support of Alnylam Quality.Summary of Key Responsibilities:
• Enhance and maintain documentation control processes and systems
• Manage the Periodic Review program. Track metrics. Assist customers in meeting commitment dates. Provide 90 day look ahead on upcoming periodic review due dates. Assist managing past due periodic reviews with document.
• Streamline, develop and maintain SOP’s and supporting documents to strengthen the Document Control and Records Management processes in accordance with corporate and regulatory requirements.
• Support activities associated with the implementation of an electronic Document Management System (eDMS).
• Provide guidance and training to users on writing of SOP’s and other documents.

Manager of Facilities & Engineering Document Control and the Computerized Maintenance Management Systems (CMMS). In charge of design, validation, process improvements including training and change management associated with Facilities and Engineering systems and programs.Responsible for managing the business process, functions and personnel supporting.

New York, New York, US

Bachelor Of Science - Bs, Business Administration And Economics

Civil Engineering