Christian Czerwonka
Sr. Manager Global Compliance at Abbott Molecular Inc.
- Role
- Sr Manager, Global Compliance at Abbott
- Location
- Kenosha, WI, US
- LinkedIn followers
- 500 followers
Experience
Sr Manager, Global Compliance
Jun 2018 — Present · Des Plaines, IL, US
Abbot Molecular Division (AMD) Leader of internal audit strategy; responsible for management of activities to improve the AMD Quality System, audit readiness and compliance across the division. o Division owner of the AMD QA internal audit system and the subject matter expert for the internal audit program in external inspections. o Responsible for monitoring and reporting audit outcomes and audit finding resolution (CAPA and Effectiveness). o Evaluate published Regulatory Agency guidance, changes to external standards, actions, and audit findings to assess impact to AMD and take action to mitigate risk to business. o Schedule and conduct (or directing external partners to conduct) the Abbott Molecular Division’s annual internal quality audits to monitor the compliance and effectiveness of the Abbott Molecular Quality System.
Education
Kettle Moraine High School
High School
1984 — 1987
University of Wisconsin-La Crosse
Bachelor of Science (B.S.)
1987 — 1992
Skills
- Iso 13485
- Pharmaceutical Industry
- Fda
- Change Control
- Design Control
- Supplier Quality
- Quality Control
- Gmp
- Medical Diagnostics
- Quality Assurance
- Validation
- Manufacturing
- Medical Devices
- Capa
- Quality System
- Quality Auditing
- 21 Cfr Part 11
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