Managed and oversaw the entire Quality Management System to ensure compliance with 21 CFR 820Drove CAPA completion in response to FDA Inspection 483sDevelopment and implementation of company SOPs, specifications, and validation reportsOpenly collaborated with internal departments regarding continuous improvement specific to the QMSExamined and evaluated Quality and Regulatory risks and notifies Executive Management proactively/promptly of potential non-compliance and other findings Reviewed, investigated and completed customer complaints

Relocated from the United Arab Emirates to the island of Cyprus for my husband's work during the Covid-19 pandemic. It took over a year to have my immigration resident permit processed so I was unable to work during this time. Moving to a Mediterranean island during a pandemic has taught me to be flexible, gain new levels of adaptability and just take each day as it comes.

• Created an ISO 9001: 2015 compliant document management system• Created a new standard format for all forms and SOPs• Worked with subject matter experts to review and update all department documents• Worked with subject matter experts to identify document gaps and create new documents as needed• Identified and mapped out all key department processes

In November of 2014 I had been working at Sultan Healthcare but the company location was closed and moved out of state. At the same time a work opportunity for my husband became available in the United Arab Emirates so I relocated there with him. Due to the language barrier I was unable to gain acceptable employment until 2019. Living abroad has strengthened my ability to be resourceful and fearless. No matter where in the world I have lived I have learned we are all just human beings trying to live our best life.

• Created copies and assembled files for current and new product government submissions• Created cover letters and other documents as needed to ensure regulatory submissions were complete• Reviewed entire product portfolio for label compliance to regional labeling requirements• Researched regulatory requirements for assigned geographies, which included but not limited to USA, Canada, EU, UAE, Mexico, Russia, Japan, Australia and Singapore• Monitored emerging trends and integrated new requirements into department SOPs • Collaborated with business partners in gathering and submitting product submission documents and samples to maintain product licenses• Provided regulatory support to marketed and new products• Generated status reports, slides and summary tables of regulatory data and information for internal and external stake holders• Implemented and maintained an international country registration database to track submissions• Maintained regulatory library country registration files, amended and updated as necessary• Worked with Marketing Team and graphic designer to make the proper label modifications • Reviewed and approved product labeling per company requirements• Evaluated and updated as necessary Regulatory and Quality Assurance SOPs• Implemented company transition to an electronic document system, SmartSolve• Supported the Divisional Complaint Officer with Trackwise complaint intake, investigation, product testing and customer response letters• Performed QA/RA Manager responsibilities as needed including reviewing product transportation temperature deviations and approving validation reports.• Conducted internal and external audits • Supported QA/RA Manager during inspections/audits by the FDA, notified bodies, corporate audits or other international bodies

I left my position at Genentech and moved to Copenhagen to be with my now husband. Moving outside the USA for the first time was difficult. I had spent a year during university in Copenhagen so I knew some Danish and was familiar with the city. This break in my career gave me a chance to relax, meet new people and enjoy life after 9 years working in the fast paced environment of the biotechnology sector. In late 2009 we moved back to the USA to Hoboken, New Jersey for my husband's work and I began looking for a new position eventually working at Sultan Healthcare.

• Manufacturing technical support for clinical and marketed large scale mammalian cell culture and initial recoveryo Investigate, troubleshoot and improve manufacturing processeso On-call response 24/7 in a fast pace environment• Create and revise manufacturing, regulatory and validation documents for both upstream and downstream procedures• Presentations to manufacturing management to help them make timely decisions• Provided classroom and hands-on trainings on lab instruments, large scale manufacturing equipment, and validation operations• Provided scientific support for interactions with regulatory agencies and business partners• Worked with automation to update controller interface for product campaigns• Worked with Validation group to coordinate collection of cleaning validation sampling for large scale CHO manufacturing• Worked with validation and QA on resolving equipment cleaning failure issues • Entered and retrieved data from company computer systems • Served as a representative on cross functional, project and multiple product start-up teams• Member of the large scale manufacturing centrifuge technology team• Installed new instrumentation on GMP manufacturing floor

• Expert on all manufacturing equipment and procedures in cell culture manufacturing area• Performed daily cell count assays to ensure product quality• Cleaned and sterilized equipment for GMP processing• Trained new technicians on manufacturing standard operating procedures• Manufacturing skid owner• Provided feedback on written procedures• Collected and submitted validation samples• Assisted process development on new large scale product procedures and troubleshooting• As needed performed lead technician responsibilities