Kim VanVactor
American Canyon,CA
Summary
Quality Assurance leader with 20 years of experience driving cGMP compliance across deviation investigations, CAPAs, change controls, and lot release. Proven ability to collaborate cross-functionally to resolve issues efficiently and strengthen quality systems. Recognized for building high-performing teams and maintaining a commitment to continuous learning and operational excellence. Demonstrated success reducing manufacturing-related major deviations through targeted process improvements and focused cross-functional training.
Experienced with quality assurance strategies and methodologies, ensuring high standards and compliance. Utilizes keen attention to detail and robust analytical skills to identify and resolve issues efficiently. Track record of fostering collaborative environment to achieve consistent, high-quality outcomes.
Diligent Senior Manager with strong background in quality assurance management, ensuring product excellence and compliance. Led successful quality initiatives that enhanced performance and minimized defects. Demonstrated ability in process improvement and team leadership.
Overview
23
23
years of professional experience
Work History
QA Ops Senior Manager
BioMarin Pharmaceuticals
Novato
05.2024 - Current
- Negotiated meaningful development opportunities and assigned targeted stretch projects to accelerate team members' skill growth and career progression.
- Reduced manufacturing-related major deviations at the Novato site by implementing targeted process improvements and delivering focused training to cross-functional teams.
- Served as a core team member in redesigning deviation and CAPA processes, contributing to streamlined workflows, improved clarity, and stronger regulatory alignment.
- Enhanced ATS performance by implementing visual board management practices that improve transparency, accountability, and daily operational execution.
- Improved cycle times for QMS record closure through data-driven prioritization and collaboration—achieved efficiency gains without compromising compliance or quality standards.
- Supported site leadership and represented Quality in discussions with FDA inspectors during the 2025 inspection, contributing to a strong inspection outcome.
- Mentored technical managers and junior QA staff to support professional development, strengthen quality culture, and promote DEI principles across the organization.
QA Technical Manager
BioMarin Pharmaceuticals
Novato, CA
06.2019 - Current
- Oversaw major and moderate GMP investigations, RCARs, and CAPAs, ensuring timely, thorough, and compliant resolution aligned with site and global quality expectations.
- Demonstrated strong communication and influencing skills by presenting complex quality concepts and persuasive data-driven recommendations to QPs, senior leadership, and regulatory inspectors.
- Presented investigation outcomes and CAPA strategies during cross-functional meetings and management reviews, driving alignment and informing quality system improvements.
- Served as manager for the on-call hotline rotation, providing real-time support for product-impacting issues during nights, weekends, and off-hours manufacturing.
- Provided actionable feedback to site leadership that informed enhancements to the deviation process and strengthened investigation effectiveness.
- Conducted GMP-focused risk assessments and FMEAs, enabling proactive identification and mitigation of operational and compliance risks.
- Led and mentored Quality team members—supporting development, performance, and continuity during another manager's maternity leave.
- Collaborated with cross-functional teams to identify quality risks and implement corrective actions.
Senior QA Associate
BioMarin Pharmaceuticals
Novato, CA
09.2017 - Current
- Provided quality oversight for manufacturing change controls across multiple manufacturing sites, ensuring compliance and risk mitigation.
- Reviewed executed batch records and approved master documents, ensuring completeness, compliance, and readiness for inspection and lot disposition.
- Executed secondary and intermediate lot disposition activities, including preparation and verification of FBDS release documentation to support timely product release.
- Delivered on-the-floor quality support for manufacturing, resolving issues in real time and partnering with product stakeholders to maintain uninterrupted operations.
- Contributed to smooth audit execution by serving as a volunteer scribe, database coordinator, and runner.
- Led quality assurance initiatives to enhance product integrity and compliance with regulatory standards.
Sr QA Associate
Genentech/Roche
10.2012 - 08.2014
- Provided quality oversight for upstream manufacturing deviations and investigations, ensuring timely, thorough root cause analysis and compliant resolution.
- Communicated complex technical and quality information during cross-functional meetings, facilitating alignment and informed decision-making.
- Actively contributed to Kaizen workshops, identifying inefficiencies and implementing improvements to strengthen quality processes and operational performance.
QA Supervisor
Johnson & Johnson
Vacaville
03.2003 - 09.2011
- Led multiple Quality teams, including Lot Release, Product Complaints, Training, and Doc Control, ensuring cohesive operations and consistent adherence to GMP expectations.
- Coordinated, delivered, and continuously improved annual GMP training for the Vacaville site, strengthening quality culture and inspection readiness.
- Partnered with department leaders to achieve 95% on-time training compliance, driving accountability and proactive training management.
- Six Sigma Yellow Belt certified, applying process improvement methodologies to reduce waste and strengthen operational efficiency.
Education
B.S. - Microbiology
California Polytechnic State University
San Luis ObispoProfessional Program Regulatory Affairs -
UC Berkeley Extension
BerkeleySkills
- Lot Release Management: Oversee product disposition processes to ensure timely release while safeguarding compliance and patient safety
- Compliance Leadership: Ensure proactive compliance with US/EU GMPs and internal quality standards through strong governance and oversight practices
- Investigation & CAPA Strategy: Lead strategic oversight of major and critical deviations and CAPAs, improving cycle time and driving systemic quality improvements
- Change Control Governance: Provide expert evaluation of regulatory- and validation-critical changes to maintain compliance and minimize operational risk
- Quality Systems & Documentation: Champion robust document lifecycle management within Veeva Vault to support inspection readiness and procedural accuracy
- Advanced Root Cause Analysis: Facilitate cross-functional problem-solving using data-driven RCA and DMAIC methodologies
- Quality Risk Management: Strengthen risk-based decision-making through effective FMEA application and risk mitigation planning
Timeline
QA Ops Senior Manager
BioMarin Pharmaceuticals
05.2024 - Current
QA Technical Manager
BioMarin Pharmaceuticals
06.2019 - Current
Senior QA Associate
BioMarin Pharmaceuticals
09.2017 - Current
Sr QA Associate
Genentech/Roche
10.2012 - 08.2014
QA Supervisor
Johnson & Johnson
03.2003 - 09.2011
B.S. - Microbiology
California Polytechnic State University
Professional Program Regulatory Affairs -
UC Berkeley Extension