-Business Process Owner responsible for developing and implementing Amgen’s raw material commercialization process. This strategy incorporates a phase appropriate approach to raw material qualification, characterization and specification development. -Supplier Quality Lead for implementation of Single Use Systems (SUS) at Amgen.• Development of Technical Requirements for Drug Substance and Drug Product use.-Responsible for direct interactions with Amgen’s suppliers which include:• Supplier Change Notifications and Specification Development.• Lead auditor role for supplier audits.• Raw material Non Conformances and supplier investigation.• Residual Solvent, Animal Derived Materials and Single Source risk management.• Supplier on-boarding (Audits and Quality agreements).-Supplier Quality Management (SQM) Subject Matter Expert (SME) for all raw material categories (Excipients, Chemicals, SUS, Filters, Resins, Media, SUS)-SQM representative on the Global Raw Material Network-Quality representative on Amgen’s Comparator Studies Team responsible to developing business and quality strategies for the use of manipulated and non manipulated comparators in Amgen’s clinical studies.-Certified Risk Facilitator responsible for conducting raw material and process risk assessments using risk tools such as FEMA-Responsible for implementing new regulatory strategies into Amgen’s quality systems (EU risk assessment of excipients, ICH Q3D Elemental Impurities, ICH Q3C Residual Solvents etc.)

-Supervisory responsibilities for Product Quality personnel involved in the initiation, execution and operation of the Drug Substance and Drug Product stability programs, -Maintenance and oversight of the Amgen Washington (AWA) Stability Program which includes:• Development and approval of stability protocols.• Review and evaluation of ongoing and completed stability studies.• Development and approval of stability reports and related communications.• Developing stability strategies that support product commercialization and are compliant with corporate and industry standards (ICH and FDA guidance).• Authoring/Reviewing stability sections for license applications and clinical trail applications. • Assignment of expiration dates for Amgen Washington products.• Leading/participating in investigations with stability impact.• Evaluation of product temperature excursion.-Review and approval of GMP documentation including non-conformance reports, specifications, Standard Operating Procedures (SOPs), validation protocols (IQ, OQ), Change Controls and equipment work orders and preventative maintenance (PM).

-Responsible for evaluating: quality systems, assessing regulatory compliance and managing quality oversight of contract manufactures, testing labs, product packagers and distributors and raw material/component suppliers at Immunex.-Maintenance of Commercial Quality Organization (CQO) audit program, including leading and participating in vendor audits, audit reports, related communications, and assessment of audit responses and tracking corrective actions.-CQO representative in working groups or task forces for raw material sourcing.-Review of documentation including; deviations/investigations, product complaints, specifications, batch records, SOPs and validation protocols.-CQO representative for internal audits in preparation of new manufacturing facility for PIA inspection.-Extensive knowledge of current Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs).-Performed batch release activities for commercial product manufactured at contract facilities (BIPharma)-Represented Immunex/Amgen as person in the plant (PIP) at Genentech.

-Responsible for: quality operations, compliance issues and administrative duties at SYNSORB.-Disposition of finished Drug Product.-Disposition and assessment of deviations.-Preparing SYNSORB new manufacturing facility for a PAI (cGMPs, Validation, Supplier Quality Assurance, Internal Audit Program, cGMP training program etc.).-Member of the NDA, NDS and IND submission teams.-Implemented a new controlled documentation system at SYNSORB-Review and signature of SOPs and Batch Records.-Reviewing of clinical procedures for regulatory compliance, auditing clinical sites (cGCPs)-Writing, reviewing and approving of stability protocols (ICH) -Auditing of Contract Research Organizations for GCPs-Reviewing and sourcing preclinical studies (GLPs)

-Responsible for all quality operations, compliance issues and the administrative duties at NaPro.-Disposition of finished A.P.I.-Member of the compliance team preparing new manufacturing facility for a PAI.-Implementation of different groups at the Oldfield facility (Validation, Supplier Quality Assurance, Internal Audit Program).-Identifying, investigating and evaluating deviations.-Issuance and closure of Nonconformance reports.-Auditing Task.