Anne Parsons
Senior Director Quality at Vizgen
- Role
- Senior Director Quality at Vizgen
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Anne Parsons
Director and Global Quality Process Owner providing leadership and subject matter expertise for global processes including complaint management, electronic quality management system, CAPA, and quality management review. Drives global consistency and best practices while supporting site-level decision making. Serves as a strategic partner to drive the mission of LumiraDx utilizing strong business acumen and a balanced approach.Key areas of responsibility• Responsible for establishing and maintaining quality processes that support the global infrastruction across multiple sites and affiliates within the LumiraDx business. Global processes will include, but not be limited to: complaint management, CAPA, quality management review, and e-QMS.• Serves as Quality Management Representative for LumiraDx at global level; drives quality and compliance communications and decision-making processes with senior leadership.• Provides guidance and serves as an internal subject matter expert on quality management systems according to 21 CFR 820 and ISO 13485. • Responsible for establishing, tracking and reporting global KPIs in accordance with LumiraDx expectations.• Leads a team of senior professionals.• Serves as primary contact and representative of global processes during audits and inspections. Takes responsibility to manage and close findings.• Provides leadership in problem solving and root cause analysis. Proactively identifies and mitigates risk. Drives continuous improvement.• Leads a culture of proactive partnership and accountability.
Experience
Senior Director Quality
Feb 2025 — Present · Cambridge, MA, US
Skills
- Quality Assurance
- Biotechnology
- Research and Development (R&D)
- R&D
- Iso 13485
- Validation
- 21 Cfr Part 11
- Verification and Validation (V&V)
- Corrective and Preventive Action (Capa)
- Good Laboratory Practice (Glp)
- Medical Devices
- Capa
- Glp
- Life Sciences
- Risk Assessment
- U.s. Food and Drug Administration (Fda)
- Fda
- Quality System
- V&V
- Gmp
- Design Control
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.