Debbie Garvin
Associate Director, Quality Management Systems & Training, Larimar Therapeutics
- Role
- Associate Director, Quality Systems and Training at Larimar Therapeutics Inc.
- Location
- Pottstown, PA, US
- LinkedIn followers
- 500 followers
About Debbie Garvin
I am a highly-motivated, efficient, team-oriented individual with an extensive quality, compliance, and validation background with a solid reputation of reliability and dedication.Skills Summary:• Veeva implementation and system administration• TrackWise implementation and system administration• MasterControl system administration• Project Management / Leadership • Advanced Quality Assurance/Quality Systems/Compliance Experience • Regulatory Compliance Experience (Field Alert & Recall Processing)• Preparation of metrics for site and regional quality councils. • Audit / Inspection Experience• Data Integrity Knowledge/Experience• Advanced Validation Experience • SOP, deviation, and CAPA creation, review and approvals.• Demonstrated Project Management Skills • Knowledge of MS Word, Access, Excel, Powerpoint, Visio, Project, and Minitab• Greenbelt Trained (Process Excellence) • Third-party Quality Assurance Experience (Clinical Contract Manufacturer’s)• Knowledge of Risk Assessment and root cause analysis techniques (FMEA, fishbone diagrams, 5-Whys, Contradiction Matrix)• 27 years of cGMP experience (Manufacturing, Validation, and Quality Assurance)• Extensive knowledge of pharmaceuticals (drugs); growing knowledge of medical device industry.
Experience
Associate Director, Quality Systems and Training
Apr 2024 — Present · Bala-Cynwyd, PA, US
Education
Haddonfield Memorial Highschool
High school diploma
1988 — 1992
Lehigh University
B.S. in Biology, Biology, General
1992 — 1996
Skills
- Fda Gmp
- Lims
- Process Improvement
- Medical Devices
- Six Sigma
- Gxp
- Aseptic Processing
- Capa
- Pharmaceutics
- Biotechnology
- 21 Cfr Part 11
- Regulatory Requirements
- Protocol
- Manufacturing
- Life Sciences
- Fmea
- Quality Assurance
- Quality Management
- Deviations
- Technology Transfer
- Gmp
- Continuous Improvement
- Biopharmaceuticals
- Change Control
- Gamp
- Documentation
- Iso 13485
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Cleaning Validation
- Cross-Functional Team Leadership
- Trackwise
- Regulatory Affairs
- Validation
- Regulatory Submissions
- Leadership
- Quality System
- V&V
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