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Jackie Simon is listed as Driving Collaborative Excellence in Project Management and Team Leadership | Championing Performance-driven Cultures and Regulatory Compliance in Quality Operations at Emergent BioSolutions, based in Dayton, Ohio, United States. AeroLeads shows a work email signal at alkermes.com and a matched LinkedIn profile for Jackie Simon.
Jackie Simon previously worked as Regulatory Affairs Manager at Emergent Biosolutions and QA Supervisor at Cil Isotope Separations, Inc.. Jackie Simon holds Bachelor Of Science, Chemistry from Wright State University.
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AeroLeads found 1 current-domain work email signal for Jackie Simon. Compare company email patterns before reaching out.
Jackie Simon is a Driving Collaborative Excellence in Project Management and Team Leadership | Championing Performance-driven Cultures and Regulatory Compliance in Quality Operations at Emergent BioSolutions. They possess expertise in research and development, mdr, supplier evaluation, gmp, ectd and 44 more skills. Colleagues describe them as "I supervised Jackie at Eurand/Aptalis during her tenure in Regulatory Affairs. Jackie was exceptional in several areas of drug development. Her attention to detail and analytical background enabled her to interpret and apply FDA guidance information across regulatory, quality and compliance areas. Jackie was fearless in taking on projects for both regulatory submissions and quality/compliance systems. Jackie was a "go to" specialist who displayed professional competence beyond her experience. Her willingness to learn quickly and attention to detail made her an exceptional Regulatory Affairs professional. Jackie's ability to cover analytical, quality, compliance and regulatory affairs would make her a valued asset for any organization. I thoroughly enjoyed working with her and had confidence that anything she did would be done well and completed on time - both of which are critical aspects for Regulatory Affairs. I highly recommend Jackie and I look forward to the next opportunity to work with her again.", "I worked with Jackie on a number of projects during her time at X-spine systems. She was always professional, thorough and knowledgeable. She was easy to work with and always tackled each new challenge enthusiastically. She's very approachable and friendly. A great team player. I can't recommend her highly enough! Aaron Gord Project Engineer II X-Spine Systems", and "I worked with Jackie for the 4 years I was General Manager at Eurand, Inc. During that time Jackie demonstrated a relentless pursuit of knowledge, detailed research, and passion for excellence. I was always able to count on all information Jackie provided as accurate and that her work product was impeccable. Jackie's integrity is beyond reproach. Jackie has a wealth of knowledge and is readily available to share her experiences. I thoroughly enjoyed working with her and truly hope to have the opportunity to work with her again."
Listed skills include Research And Development, Mdr, Supplier Evaluation, Gmp, and 45 others.
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A career timeline built from the work history available for this profile.
Gaithersburg, Maryland, Us
Operated in a global capacity as RA Change Control Coordinator, assessing change controls for their regulatory filing implications. Orchestrated a project to standardize Veeva RIM metadata, enhancing data extraction via system-generated reports. Implemented a process for global annual drug volume reporting, as mandated by the CARES Act.
Led a team of QA Associates overseeing all GMP activities site-wide, including operations, supplier management, equipment calibration and maintenance, laboratory investigations, document management, inspections, internal audits, deviation/CAPA systems, production record reviews, and material release. Trained by Veeva to act as an administrator during implementation of new Veeva Vault QMS.
Dublin, Ie
Headed a team of QA Specialists responsible for overseeing laboratory and deviation investigations, CAPAs and effectiveness checks, stability protocols and reports, work order processing, data integrity risk assessments, equipment qualification, method verification/validation, work order processing, and change control across QC, Analytical Development, and Microbiology/Environmental Monitoring laboratories within an aseptic manufacturing setting.
Dublin, Ie
Established and led a newly-formed QC Compliance Team tasked with overseeing the site’s stability program, laboratory training, and data review.
Cambridge, Cambridgeshire, Gb
Coordinated and managed health authority inspections. Provided CMC compliance oversight of projects and changes. Led teams dedicated to advancing operational excellence and enhancing employee engagement, driving corporate initiatives throughout the organization at all levels.
Cambridge, Cambridgeshire, Gb
Oversaw the QC Team responsible for managing the site’s stability and raw material testing programs. Held the role of QC Integration Project Manager, leading post-acquisition laboratory integration efforts and milestones. Directed laboratory investigations; conducted personnel reviews; developed and implemented analyst training certifications.
Lawrenceville, New Jersey, Us
Lawrenceville, New Jersey, Us
Other employees you can reach at emergentbiosolutions.com. View company contacts →
Latavian Mcnair
Colleague at Emergent BiosolutionsBaltimore City County, Maryland, United States
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Heidi Swaim
Colleague at Emergent BiosolutionsBaltimore, Maryland, United States
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Mark M.
Colleague at Emergent BiosolutionsLong Beach, California, United States
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Jason Ghurani
Colleague at Emergent BiosolutionsDetroit, Michigan, United States
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Jason Ward
Colleague at Emergent BiosolutionsChattanooga, Tennessee, United States
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Gordon Hildebrand
Colleague at Emergent BiosolutionsWinnipeg, Manitoba, Canada
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Sharanya Bolotnyy
Colleague at Emergent BiosolutionsWinnipeg, Manitoba, Canada
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Matheus Kommeren
Colleague at Emergent BiosolutionsParkville, Maryland, United States
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Vishakha Patel
Colleague at Emergent BiosolutionsBaltimore City County, Maryland, United States
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Niki Hoffman
Colleague at Emergent BiosolutionsLansing, Michigan, United States
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Quick answers generated from the profile data available on this page.
Jackie Simon works for Emergent BioSolutions.
Jackie Simon is listed as Driving Collaborative Excellence in Project Management and Team Leadership | Championing Performance-driven Cultures and Regulatory Compliance in Quality Operations at Emergent BioSolutions.
AeroLeads has found 1 work email signal at @alkermes.com for Jackie Simon at Emergent BioSolutions.
Jackie Simon is based in Dayton, Ohio, United States while working with Emergent BioSolutions.
Jackie Simon has worked for Emergent Biosolutions, Cil Isotope Separations, Inc., Alkermes, Astrazeneca, and X-Spine Systems, Inc..
Jackie Simon's colleagues at Emergent BioSolutions include Latavian Mcnair, Heidi Swaim, Mark M., Jason Ghurani, and Jason Ward.
You can use AeroLeads to view verified contact signals for Jackie Simon at Emergent BioSolutions, including work email, phone, and LinkedIn data when available.
Jackie Simon holds Bachelor Of Science, Chemistry from Wright State University.
Jackie Simon is listed with skills including Research And Development, Mdr, Supplier Evaluation, Gmp, Ectd, Regulatory Filings, Ncmr, and Gxp.
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