Rachelle Ridge
Syracuse,Utah
Summary
Dynamic Sr. Pharmaceutical Affairs Manager with a proven track record at Biocodex USA, excelling in regulatory compliance and quality management systems. Expert in pharmacovigilance and international GMP auditing, driving operational efficiency and fostering partnerships. Adept at implementing effective strategies that enhance inspection readiness and product quality.
Overview
15
15
years of professional experience
4
4
Certifications
Work History
Sr. Pharmaceutical Affairs Manager
Biocodex USA
05.2018 - Current
- Led regulatory compliance efforts for U.S. and Canadian markets, ensuring adherence to standards for drugs, dietary supplements, and NHPs.
- Managed Health Canada NNHPD submissions, streamlining site licensing and formula review processes to meet regulatory requirements.
- Functioned as PCQI for FSMA programs while directing supplier qualifications and audits both domestically and internationally.
- Oversaw pharmacovigilance quality systems and document control processes, enhancing compliance and operational efficiency.
- Drove training initiatives to enhance regulatory inspection readiness for internal and external teams.
Quality & Compliance Manager
Biovation Labs
06.2016 - 04.2018
- Directed QA/QC for dietary supplement production, ensuring compliance with 21 CFR Part 111 and Health Canada NHP GMPs.
- Led FDA, NSF, and client audits, addressing non-conformities through effective CAPA programs.
- Developed and implemented supplier qualification and raw material testing standards to enhance product quality.
QC Compliance Leader
Reckitt Benckiser
01.2015 - 06.2016
- Ensured regulatory compliance in QC lab operations for OTC pharmaceutical manufacturing.
- Coordinated LIMS management, training, specifications, and QA deliverables across systems and teams.
- Led cross-functional teams to implement new product strategies.
- Managed supply chain operations to optimize resource allocation.
- Facilitated training sessions to enhance team performance and skills.
Sr. Lab & Document Control Manager
Global Health Industries
06.2011 - 01.2015
- Directed Unipoint-based QMS and document control, facilitating successful regulatory inspections and effective remediation efforts.
- Managed document control processes to ensure compliance with industry standards.
- Oversaw GMP laboratory testing and documentation for supplements, ensuring compliance with FDA and Health Canada regulations.
- Developed and maintained document management systems for efficient retrieval.
- Trained staff on proper documentation protocols and best practices.
Education
Bachelor of Science - Biology
University of Utah
Salt Lake City, UT12.2010
Skills
- Regulatory Compliance
- Regulatory Strategy
- Quality Management Systems
- Pharmacovigilance systems
- International GMP Auditing
- FSVP Auditing
- Electronic Quality Systems
- Analytical Testing
- Operational efficiency
- Policy implementation
- Partnership development
- Product management
Certification
- FSPCA PCQI – Preventive Controls for Human Food
- Certified Quality Auditor (CQA)
- Certified Pharmaceutical GMP Professional (CPGP)
- Certified Manager of Quality/Organizational Excellence (CMQ/OE)
Timeline
Sr. Pharmaceutical Affairs Manager
Biocodex USA
05.2018 - Current
Quality & Compliance Manager
Biovation Labs
06.2016 - 04.2018
QC Compliance Leader
Reckitt Benckiser
01.2015 - 06.2016
Sr. Lab & Document Control Manager
Global Health Industries
06.2011 - 01.2015
Bachelor of Science - Biology
University of Utah