Linda Mckusick

Linda Mckusick Email and Phone Number

Operational Compliance Manager @ Imaging Endpoints
scottsdale, arizona, united states
Linda Mckusick's Location
West Newton, Massachusetts, United States, United States
About Linda Mckusick

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

Linda Mckusick's Current Company Details
Imaging Endpoints

Imaging Endpoints

View
Operational Compliance Manager
scottsdale, arizona, united states
Employees:
121
Linda Mckusick Work Experience Details
  • Imaging Endpoints
    Operational Compliance Manager
    Imaging Endpoints Dec 2022 - Present
    United States
  • Calyx
    Associate Quality Director
    Calyx Apr 2021 - Sep 2021
    United States
    As 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.
  • Calyx
    Sr. Quality Manager
    Calyx Jul 2018 - Mar 2021
    As 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.
  • Parexel
    Project Quality Manager, Pqm
    Parexel Nov 2015 - Jun 2018
    Billerica, Ma
    As Project Quality Manager my essential function is to serve as a quality consultant to medical imaging project teams, throughout the lifecycle of the project.
  • Parexel
    Senior Project Quality Lead, Project Quality Management
    Parexel Nov 2012 - Oct 2015
    Billerica, Ma
  • Parexel
    Project Quality Lead Ii, Project Quality Management
    Parexel Mar 2010 - Nov 2012
    Billerica, Ma
  • Parexel
    Imaging Research Manager (Perceptive Infomatics)
    Parexel Feb 2006 - Mar 2010
    Billerica, Ma
    As 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.
  • Parexel
    Imaging Research Associate (Perceptive Informatics)
    Parexel Aug 2004 - Feb 2006
    Billerica, Ma

Linda Mckusick Skills

Medical Imaging Clinical Trials Pharmaceutical Industry Clinical Development Oncology Fda Clinical Data Management Inspection Edc 21 Cfr Part 11 Operations Management Gcp Cross Functional Team Leadership Medical Devices Sop Cro Global Operations Validation Quality Management Mri Clinical Research Mentoring Training

Linda Mckusick Education Details

  • Fitchburg State University
    Biology, Cert. In Secondary Education
  • College Of Southern Maryland
    College Of Southern Maryland
    Secondary Education
  • Ultrasound Diagnostic School
    Ultrasound Diagnostic School
    Cert. 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?

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What schools did Linda Mckusick attend?

Linda Mckusick attended Fitchburg State University, College Of Southern Maryland, Ultrasound Diagnostic School.

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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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