Loreena Sadowski
Director - Global Quality - Inspection Management at Bristol Myers Squibb | Langhorne, Pennsylvania, United States
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Loreena Sadowski currently serves as the Director of Global Quality - Inspection Management at Bristol Myers Squibb, where she spearheads a dedicated team focused on ensuring compliance with Good Clinical Practice (GCP) across all therapeutic areas. With a wealth of experience in the pharmaceutical industry, Loreena plays a pivotal role in preparing for and managing GCP inspections conducted by various regulatory agencies, including the FDA. Her expertise in clinical quality and regulatory affairs is instrumental in navigating the complexities of pharmaceutical development, ensuring that the processes in place not only meet stringent compliance standards but also facilitate the timely delivery of life-saving medicines to patients.
Under her leadership, the Inspection Management team is tasked with conducting comprehensive risk assessments and optimizing inspection preparation processes. Loreena collaborates closely with global study teams and GxP audit and compliance functions, fostering a culture of continuous improvement and proactive risk management. Her strategic approach to inspection management not only enhances operational efficiency but also strengthens Bristol Myers Squibb's commitment to quality and patient safety.
Loreena's career in pharmaceutical development has been marked by her ability to bridge the gap between operational leaders and regulatory requirements, ensuring that all stakeholders are aligned in their pursuit of excellence. Her skills in change control, clinical trial management systems (CTMS), and standard operating procedures (SOP) further bolster her team's capabilities, making them well-equipped to handle the dynamic challenges of the industry. As she continues to lead her team in optimizing processes and ensuring compliance, Loreena remains focused on the ultimate goal: delivering innovative therapies to patients in need.
Director - Global Quality - Inspection Management at Bristol Myers Squibb in November 2021 to Present
Senior Director - RDQ GCP Inspection Management at Bristol Myers Squibb in September 2022 to Present
Director - Regional Clinical Compliance - Americas at Bristol Myers Squibb in September 2018 to December 2021
Compliance Specialist at Bristol Myers Squibb in September 2007 to September 2018
Senior Site Monitor at Bristol Myers Squibb in December 2000 to September 2007
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Clinical Quality
GCP
Regulatory Affairs
CAPA
Pharmaceutical Industry
FDA
ICH-GCP
CRO
Sop
Clinical Development
21 CFR Part 11
Oncology
Therapeutic Areas
Clinical Monitoring
CTMS
Regulatory Requirements
Pharmacovigilance
Clinical Trials
Change Control
Regulatory Submissions
Medical Writing
Drug Development
EDC
Good Clinical Practice (GCP)
SOP
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Discover more about Bristol Myers SquibbWhat is Loreena Sadowski email address?
Email Loreena Sadowski at [email protected]. This email is the most updated Loreena Sadowski email found in 2026.
What is Loreena Sadowski phone number?
Loreena Sadowski phone number is +16095102627.
How to contact Loreena Sadowski?
To contact Loreena Sadowski send an email to [email protected]. If you want to call Loreena Sadowski try calling on +16095102627. (updated on November 05, 2024)
What company does Loreena Sadowski work for?
Loreena Sadowski works for Bristol Myers Squibb
What is Loreena Sadowski's role at Bristol Myers Squibb?
Loreena Sadowski is Director - Global Quality - Inspection Management
What industry does Loreena Sadowski work in?
Loreena Sadowski works in the Biotechnology Research industry.
Loreena Sadowski Email Addresses
Loreena Sadowski Phone Numbers
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