Beth-Ann Marchese Email & Phone Number

Paris, France, Fr

System Owner for Product Events and Complaints Investigations for Specialty Care External Supply site within Sanofi.

Paris, France, Fr

System Owner for Records Management for Specialty Care External Supply site within Sanofi.

Paris, France, Fr

QA Compliance Specialist working to integrate the former Bioverativ into the Sanofi Biologics Network. Current projects include:Working with SMEs to align the Bioverativ site with the quality systems for Sanofi, Sanofi Biologics Network, and Biologics Corporate Quality External Supply

Paris, France, Fr

Developed, wrote, and revised GxP documents, supporting corporate- and site-level Quality Management Systems (QMS). Works closely with SMEs in quality assurance and control; facility, utility, environment, equipment, and instrument control and management; personnel and subcontractor training and qualification; product and process development; risk management; production control; analytical testing development and lifecycle management; material control, storage, and transportation; and validation to ensure that all corporate- and site-level GxP standards, procedures, practices, and work instructions comply with U.S., EU, and other international regulations. Achievements include:Provided technical writing, training development, and project management support to multiple cross-functional teams of SMEs representing corporate and site-level personnel to create and revise corporate standard, global operating procedures, global best practices, site-level SOPs and related training materials supporting implementation of corporate- and site-level Quality Management Systems, including the following special projects:Creation and implementation of the Genzyme QMS (before the Sanofi acquisition) in response to the 2010 FDA Consent DecreeAligning the Genzyme QMS with the Sanofi QMS as part of the broader integration efforts following Sanofi’s acquisition of GenzymeCreation and implementation of a QMS for a new manufacturing site employing continuous biomanufacturing technology Providing technical writing and project management support for multiple cross-functional teams of SMEs involved with creating and revising site-level procedures supporting QMS alignment between the Bioverativ and Sanofi following Sanofi's acquisition of the company

Paris, France, Fr

Developed, wrote, and edited training materials supporting implementation of the Genzyme Quality System and worked with multi-disciplinary teams to create global quality standards for management control, manufacturing, materials storage and transport, product development, quality management, regulatory and cGMP compliance, supply chain, and validation.Achievements include:Developed training modules that supported implementation of the Genzyme Global Quality SystemWorked with Subject Matter Experts to ensure training modules met the needs of key stakeholdersDelivered live training outlining the requirements promulgated in the newly created global quality standards Developed and managed tools to help Genzyme sites comply with the new global quality standards

Cambridge, Massachusetts, Us

Developed, wrote, and edited training documents and certification exams for pharmaceutical sales representatives and district managers that met the regulatory, legal, and medical requirements of the clients. Products included pharmaceuticals and biologics in the cardiovascular, endocrinology, gastrointestinal, immunological, infectious disease, neurology, oncology, respiratory, surgical, and over-the-counter markets. Achievements include:Wrote proposals and estimated budgets for training products tailored to the needs of the clientDesigned, researched, and wrote content for interactive and paper-based self-training modules for pharmaceutical professionals employed by companies ranging in size from small-cap start-ups to Fortune 500 international corporations Designed, researched, and wrote content for workshop-based training, including participant workbooks, workshop leader guides, and PowerPoint presentations Translated complex medical information about disease states, patient treatment, product overviews of competitors, clinical studies, and other complex scientific and regulatory documents for a lay audience Worked closely with corporate medical, legal, and regulatory pharmaceutical personnel to ensure all produced materials met and exceed all client needsWorked closely with in-house project managers to determine client needs and develop training and educational materials that met those needs

Master'S Of Science, Regulatory Affairs And Quality Assurance

Certificate In Biomanufacturing, Fundamentals Of Biomanufacturing: A Hands-On Approach

Attended, Biology/Biological Sciences, General

B.S., Journalism