Linda McKusick
Manager, Operational Compliance
- Role
- Operational Compliance Manager at Imaging Endpoints
- Location
- West Newton, MA, US
- LinkedIn followers
- 500 followers
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
Experience
Operational Compliance Manager
Dec 2022 — Present · US
Education
Ultrasound Diagnostic School
Certificate, Cert. Diagnostic Medical Ultrasound
1994 — 1996
Fitchburg State University
BA, Biology, Cert. in Secondary Education
1999 — 2003
College of Southern Maryland
AS, Secondary Education
1998 — 1999
Skills
- Cross-Functional Team Leadership
- Edc
- Quality Management
- Operations Management
- Clinical Trials
- U.s. Title 21 Cfr Part 11 Regulation
- Inspection
- Gcp
- 21 Cfr Part 11
- Clinical Data Management
- Mentoring
- Oncology
- Clinical Development
- Validation
- Mri
- Medical Devices
- Clinical Research
- Pharmaceutical Industry
- Sop
- Fda
- Training
- CRO
- Global Operations
- Medical Imaging
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