Scott Bobbitt Email & Phone Number

London, GB

Redwood City, California, US

Responsible for assuring the quality and compliance of cell, gene and CAR-T manufacturing, testing and distribution practices. Maintain and lead the quality organization of for phase appropriate quality systems, support regulatory filings, inspection preparedness internally and externally. Manage the quality fiscal budget. Ensure the operational business.

Responsible for assuring the quality and compliance of Cell & Gene therapy manufacturing, testing and distribution practices at the site. Maintain and lead the quality organization for inspection preparedness internally and externally. Manage the quality fiscal budget of approximately 20 million dollars. Ensure the operational business is in compliance.

Menlo Park, CA, US

Menlo Park, CA, US

• Manage the transition of quality from a development organization to include commercial operations. Lead the quality organization in PAI preparedness internally and externally. Provide support to CMO’s for Dermira.
• Successfully implementing commercial quality systems.
• Successfully support audits of CMO’s and host all Regulatory Audits of Dermira products.
• Successfully reorganizing the quality organization to support commercial QA and QC teams.

Basel, Baselstadt, CH

• Provide full accountability for managing quality aspects at contract manufacturing organizations (CMOs) that supply Biopharmaceutical sterile products for Novartis BTDM ESO. From a quality aspect, I ensure that the.
• Successfully provide quality oversight at 2 CMO sites that manufacture 2 products.
• Successfully supported audits of CMO, ESO and Regulatory Audit of Novartis Sites.
• Successfully onboarded and manage 2 Third Party contract laboratories

Basel, Baselstadt, CH

• Provide full accountability for managing divisional quality plan objectives in accordance with divisional goals. Apply strategic planning, prioritization, and project management skills toward consistently achieving.
• Successfully leads and manage the Divisional Quality Assurance on the Shop Floor operational excellence multi-year program. This program consisted of defining and implementing divisional governance, cross-site best.
• Divisional SME for the site quality risk assessment process and facilitated a new process for Novartis Vaccines to perform, review, approve and communicate SQRA outcomes and improvement plans.
• Successfully supported Italian facility in a good outcome for their FDA inspection. Provide deviation support, Quality Assurance on the Shop Floor training and guidance for quality oversight inquiries.
• Manage and facilitate the divisional governance review boards for deviations and change controls.
• Successfully prepared and supported multiple global manufacturing sites for divisional and group audits that were rated as satisfactory or good.

Paris, France, FR

• Maintain full accountability for managing all aspects of day-to-day quality assurance activities in accordance with organizational goals. Apply strategic planning, prioritization, and project management skills toward.
• Drafted, submitted, and updated Quality Technical Agreements, tracked and followed-up on Continuous Improvement Projects, and oversaw the cGMP training program.
• Effectively analyzed internal processes to define inefficiencies and provided expert recommendations to maximize productivity and streamline workflow.
• Enhanced operational performance by spearheading the internal and external audit program for US and Latin American facilities.
• Successfully globally implemented, integrated, and validated the Clinical Supplies Inventory Management System.
• Oversaw the release of aseptic, solid oral dosage, and soft gel products.

San Diego, CA, US

• Strategically planned and coordinated key projects to ensure on-time, requirements-compliant completion while overseeing quality standards. Led the administration of on-site vendor compliance as Amylin’s.
• Tracked and updated Quality Agreements between Amylin and external contractors, as well as authoring quality manuals, policies, and standard operating procedures, further illustrating exceptional written communication.
• Monitored the production and process control systems at UK contract manufacturing facility, as well as establishing the facility for successful PAI and participated in audit.

Brussels, BE

• Successfully built and steered teams to maximize performance in consistently delivering projects on time and within budget in a fast-paced, time-sensitive environment requiring superior strategic planning.
• Spearheaded a wide array of different projects, including overseeing the US GMP Quality System, creating a Quality Manual for defining Global Quality Management Systems, and managing the Internal and External Audit.
• Contributed information gathering, needs assessment, and analytical skills toward effectively and diplomatically responding to customer issues for timely resolution.
• Tracked and monitored the handling and preparation for regulatory inspections.

Brentford, Middlesex, GB

Ms, Quality Assurance

Education record