Linda Mckusick Email and Phone Number
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I am an enthusiastic Quality Management professional with over 10 years of experience working in the regulated biopharmaceutical industry, focused on Clinical Research trials. I am adept at leading and motivating cross-functional teams to manage study related risks and process improvements. I encourage others to use critical thinking skills to identify efficient solutions to complex challenges. I drive results through productive collaboration with teams to ensure deliverables are met with the highest level of quality. Key areas of expertise: ● Providing consultancy to inter-departmental teams on regulations, policies, and procedures ● Training and mentoring a global team of 8 Operational Compliance Specialist and Managers● Performing project level and operational risk assessment and mitigation planning activities● Understanding complex workflows to provide constructive feedback in document & SOP review● Documenting and overseeing the execution of Deviations, CAPAs, and effectiveness checks● Guiding global teams in the identification and implementation of process improvements● Audit and regulatory inspection support, including management of audit findings to closure● Comprehensive understanding of change control, change management procedures● Skilled at utilizing and troubleshooting quality systems and applications
Imaging Endpoints
View- Website:
- imagingendpoints.com
- Employees:
- 121
-
Operational Compliance ManagerImaging Endpoints Dec 2022 - PresentUnited States -
Associate Quality DirectorCalyx Apr 2021 - Sep 2021United StatesAs a leader within the Quality Management team, I serve as a quality consultant to cross functional groups throughout the organization. My responsibilities include mentoring global quality professionals to: assess risks throughout the lifecycle of a Medical Imaging research study in order to implement appropriate mitigation plans, identify process improvement opportunities, perform process authoring and review procedures, provide GxP and regulatory expertise, support for the identification, management, and prevention of quality issues and CAPAs, provide audit and regulatory inspection support, and assist with the collection and reporting and trending of quality metrics. I have 17+ years of progressive experience in the clinical research and pharmaceutical industry. I’ve demonstrated leadership and general management competencies in focusing project teams as well as individual staff on meeting project specific goals. Experienced in crafting a strategy for resource management in a highly complex project environment, to support the company vision and achieve target objectives. One key highlight of my career was when I had the opportunity to travel to India to interview, hire, and train the pioneer team of imaging research associates and managers selected to open the Hyderabad, Medical Imaging research lab. -
Sr. Quality ManagerCalyx Jul 2018 - Mar 2021As a Quality Manager, I work as part of a quality management team to prepare for and support Medical Imaging focused inspections. More than 15 years of progressive experience in the Clinical Research and Pharmaceutical industry. Demonstrated leadership and general management competencies. -
Project Quality Manager, PqmParexel Nov 2015 - Jun 2018Billerica, MaAs Project Quality Manager my essential function is to serve as a quality consultant to medical imaging project teams, throughout the lifecycle of the project. -
Senior Project Quality Lead, Project Quality ManagementParexel Nov 2012 - Oct 2015Billerica, Ma -
Project Quality Lead Ii, Project Quality ManagementParexel Mar 2010 - Nov 2012Billerica, Ma -
Imaging Research Manager (Perceptive Infomatics)Parexel Feb 2006 - Mar 2010Billerica, MaAs an Imaging Research Manager, my essential function was to ensure adequate resourcing of client projects with highly motivated and suitably developed research professionals, specialized in the Imaging portion of clinical trials. -
Imaging Research Associate (Perceptive Informatics)Parexel Aug 2004 - Feb 2006Billerica, Ma
Linda Mckusick Skills
Linda Mckusick Education Details
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Biology, Cert. In Secondary Education -
College Of Southern MarylandSecondary Education -
Ultrasound Diagnostic SchoolCert. Diagnostic Medical Ultrasound
Frequently Asked Questions about Linda Mckusick
What company does Linda Mckusick work for?
Linda Mckusick works for Imaging Endpoints
What is Linda Mckusick's role at the current company?
Linda Mckusick's current role is Operational Compliance Manager.
What is Linda Mckusick's email address?
Linda Mckusick's email address is li****@****are.com
What is Linda Mckusick's direct phone number?
Linda Mckusick's direct phone number is +197823*****
What schools did Linda Mckusick attend?
Linda Mckusick attended Fitchburg State University, College Of Southern Maryland, Ultrasound Diagnostic School.
What are some of Linda Mckusick's interests?
Linda Mckusick has interest in Collecting Antiques, Exercise, Home Improvement, Collecting Art, Reading, Gourmet Cooking, Sports, Food, Home Decoration, Health.
What skills is Linda Mckusick known for?
Linda Mckusick has skills like Medical Imaging, Clinical Trials, Pharmaceutical Industry, Clinical Development, Oncology, Fda, Clinical Data Management, Inspection, Edc, 21 Cfr Part 11, Operations Management, Gcp.
Who are Linda Mckusick's colleagues?
Linda Mckusick's colleagues are Tejkumar Kokkanti, Andre Burkett, Mary-Ann Murnion, Debbie Vang, Ashish Kumar Vidyarthi, Anamika Pandagre, Samuel Lofland.
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Linda McKusick
Columbus, Oh
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