Scott Detmer Email & Phone Number

Thousand Oaks, CA, US

Thousand Oaks, California, United States

Provide Quality oversight for development, clinical trial and pharmacovigilance activities. Assess activities conducted internally and outsourced to CROs/vendors to ensure practices are compliant with relevant cGxP (GLP, GCLP, GCP, GVP) requirements and expectations.Partner with R&D stakeholders to establish and maintain the GxP Quality Management System..

Thousand Oaks, California, United States

Ensures that CQA resources appropriately cover and support all clinical programs at Atara. o Ensures that the master audit schedule is continually updated, reflective of any identified risks from the clinical teams and programs. o Strategically implements a risk-based approach to allocate CQA resources to support clinical teams, and oversee the planning.

Thousand Oaks, CA

- Plan, implement and execute compliance programs for Atara clinical programs.- Provide GCP guidance to all phases of clinical drug development.- Assess compliance with GCP regulations and guidelines internally and externally for service providers and clinical investigator sites.- Periodically assess the adequacy of CQA Standard Operating Procedures.

Greater San Diego Area

-Ensure the quality & compliance of Halozyme’s clinical and preclinical development & clinical operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations.-Conduct QA review of draft protocols; Informed Consent Forms, aggregate safety reports, and other clinical trial specific documents, when.

Thousand Oaks, CA

-Key interface with Commercial, Safety and other functions for all Commercial Program Quality Oversight Team (CPQOT) activities.-Apply a risk based approach to Patient Support Program (PSP) vendor monitor and data reviews. Gather information about the PSP and data availability to conduct an initial monitoring visit. Conduct monitoring visits to review.

Thousand Oaks, CA

- Maintain a master project plan and schedule for assigned projects. Translate sub-team plans into actionable and measurable tasks. Provide detailed data support for portfolio management.- Conduct functional team-level risk assessment and scenario planning to support issues.- Provide operational leadership in team and/or sub-team meetings and identify.

Seattle, WA

• Lead for cross-functional Internal Process Audits (IPA) within various departments in Research & Development. Meet with functional area heads to charter an audit scope, and develop an audit plan. Lead a multimember.
• Lead for Contract Research Organization (CRO) compliance capability assessments for international and domestic toxicology facilities, central laboratories, and analytical laboratories. Work with various departments.
• Lead and perform audits of systems (database, IVRS, etc) vendors supporting clinical studies for Amgen.
• Lead and perform international and domestic site audits of clinical sites supporting Amgen clinical studies. Determine compliance gaps and help ensure patient safety.
• Assist in the management of FDA inpsections of GLP studies.
• Departmental (GLP) Liaison with various client groups / departments. Performed role of department subject matter expert (SME) for GLP activities, facing both internal client groups and main external vendors.

Longmont, CO

• Lead various offsite (corporate) supplier qualification audits for GMP vendors. Assure compliance to applicable regulations and assess risk.
• Performed/Lead for internal audits of various functions within internal departments and company manufacturing support locations.
• Perform sampling, inspection and dispositioning/release of auxillary and raw materials. Review all of the above actions to ensure GMP compliance.
• Revise company specifications and standard operation procedures.

Mba

Bachelor Of Science, Biology/Biological Sciences, General