Todd Strom Email & Phone Number

Long Beach, CA, US

San Diego, California, US

San Diego, California, US

• Meet with local and international CMO counterparts regularly to establish/clarify specific compliance requirements and determine appropriate prevention or resolution of any issues.
• Provide timely release of batch documentation (Batch Records, Packaging Records, Change Control, Deviations, etc.).
• Review and approval of regulatory submission reports.
• Provide support to the quality team on Phase III clinical trials.
• Provide review and approval of International client based Contract Service Provider (CSP) for API and Solid Dose documentation including batch records, change control, investigations, and corrective/preventive actions.
• Support ongoing QA initiatives including assembling of the Quality organization comprising the development of SOP’s, Policies, and GMP system development.

Foster City, CA, US

• Perform review and approval of product and process changes
• Provide expertise in writing and reviewing both operational and Quality SOPs.
• Meet with (Contract Manufacturing Organizations) CMO counterparts regularly to establish/clarify specific compliance requirements and determine appropriate prevention or resolution of any issues.
• Provide quality oversight of CMO investigations, and CAPA’s.
• Review and approval of change control records related to Manufacturing/CAPA specific issues.
• Conduct external CMO audits.

Ensure medicinal products are manufactured in line with all legislative obligations and ensuring the safety, quality and efficacy of the product prior to final release to market. Perform review of product and process changes especially where there are implications for patient safety, quality and compliance. Routinely make decisions with significant.

Thousand Oaks, CA, US

Responsibilities included process and product investigations across Amgen’s global manufacturing facilities; investigations include troubleshooting, root cause analysis, data analysis, report compilation and implementation/tracking/closure of corrective/preventive actions (CAPA), when necessary. I was responsible for the review of the Nonconformance/CAPA.

Thousand Oaks, CA, US

Supported the implementation of lean principals within the manufacturing area to eliminate sources of waste and improve product flow. Project management of manufacturing process improvement projects to ensure timely execution.

Thousand Oaks, CA, US

Performed process and product investigations for individual anomalous batches including troubleshooting, root cause analysis, data analysis, report compilation and implementation of corrective action, when necessary.

Basel, Basel-Stadt, CH

Performed process validations including the following: protocol development, validation testing, data collection and analysis, compilation and reporting of data, and the completion of validation reports using approved formatting standards. Managed validation-related activities including the following: production, engineering, maintenance and QA personnel.

Basel, Basel-Stadt, CH

Performed product and process evaluations relating to the product line. Activities included troubleshooting technical problems related to manufacturing processes. Performed process and product investigations for individual anomalous batches including troubleshooting, root cause analysis, data analysis, report compilation and implementation of corrective.