Judy Zdanowicz
Quality Professional
- Role
- VP, Quality at Parabilis Medicines
- Location
- Naples, FL, US
- LinkedIn followers
- 500 followers
Experience
VP, Quality
Apr 2024 — Present · Cambridge, MA, US
Implement and monitor Clinical Compliance systems to ensure Phase appropriate compliance with EU and US regulations covering GMP and GCP for investigational medicinal products (IMPs) for human use- Implement and maintain a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements- Ensure the development of appropriate controlled documents (writing, revising and approving, issuing), ensure regulatory compliance in conjunction with being ‘fit for purpose’ operationally- Ensure there is a robust GxP Vendor Management program which proactively monitors vendor performance-Manage, motivate, coach and mentor direct reports, to higher levels of management capability- Manage Global Pharmaceutical Quality Systems (PQS) associated with lot disposition, deviations, change control, product complaints, supplier qualification and oversight, GxP training and document management- Contribute to the preparation, review, and submission of regulatory CMC documents to global regulatory authorities to support clinical trials, INDs, and IMPDs- Establish and maintain programs which mitigate risk conditions and maintain inspection readiness
Education
University of Michigan
Masters, Pharmaceutical Engineering
2009 — 2016
University of Southern California
BS, Chemistry
1984 — 1988
University of Southern California
Bachelor's degree, Chemistry
Skills
- Technology Transfer
- Gxp
- Regulatory Affairs
- Lims
- Cleaning Validation
- Hplc
- Lifesciences
- Quality Assurance
- Validation
- 21 Cfr Part 11
- Fda
- Regulatory Requirements
- Gmp
- Computer System Validation
- R&D
- Sop
- Quality System
- Change Control
- Aseptic Processing
- Capa
- Quality Control
- Clinical Development
- Biopharmaceuticals
- Pharmaceutical Industry
- Glp
- V&V
- Drug Development
- Fda Gmp
- Biotechnology
- Regulatory Submissions
- Trackwise
- Cgmp Practices
- Analytical Chemistry
- Chromatography
- Iso 13485
- Ind
- Pharmaceutics
- Life Sciences
- Corrective and Preventive Action (Capa)
- U.s. Title 21 Cfr Part 11 Regulation
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