Stan Reid Email & Phone Number

Tarrytown, New York, US

• Assures Product conformance to established requirements and standards through appropriate inspection and test activities. Management Representative for all external audits (FDA, CDMR, BSI, TUV). Provide Quality.
• Review and approval of manufacturing batch records, analytical testing records, and technical documents, as well as Quality release of batch documentation for disposition.
• Authored, reviewed, and approved quality policies, SOPs, and work instructions for areas of responsibility.
• Develop, maintain, and execute an Audit schedule of current CMO partners; audit potential new CMO sites.
• Established, maintained, and executed an approved supplier qualification and change notification process as well as oversite of Quality Agreements
• Monitored performance metrics and drive continuous improvement (external supplier partners and internal processes).

• This position is responsible for managing the Quality Laboratories, Quality Assurance, Quality Systems, Regulatory Affairs, Validation and Technical Services departments of the company.
• Direct, coordinate and assure compliance in activities related to the interaction, inspections, and required submission data (DMF’s, LOA’s, etc.) to the regulatory agencies such as the Food and Drug Administration.
• Ensure that the Microbiology, Chemistry and Color Laboratories function according to approved procedures and regulations.
• Manage and coordinate the quality activities of: incoming/in-process inspections, laboratory operations, stability, compliance, documentation, product release, validations, qualifications, process improvements, product.
• Ensure Product Complaint and Incident Program functions in a timely manner relative to the coordination with the Technical Services Support Personnel, external and internal investigation process, on-site visits.
• Oversee Customer Audit Program.

Cambridge, MA, US

Cambridge, MA, US

• , The Sr. QA Manager, Supply Chain Quality is responsible for quality operations of clinical and commercial product. The responsibilities include product disposition and quality oversight of partners with respect to.
• Manage the QA interface with manufacturing and testing partners for clinical and commercial product ensure quality issues are tracked and resolved in a timely fashion.
• Prepare/manage Quality Agreements with manufacturing and testing partners for commercial product.
• Ensure deviations are fully investigated, corrective actions identified and implemented and CAPAs completed as planned..
• Review and approval of validation protocols and reports.
• Review manufacturing and testing documentation and perform batch disposition.

New York, New York, US

Thousand Oaks, CA, US

Leverkusen, North Rhine-Westphalia, DE

Leverkusen, North Rhine-Westphalia, DE

Bs, Biology, Management

B.S., Science

As, Business