Danielle Mazzaro Email & Phone Number

Ringwood, Nj, Us

Ringwood, Nj, Us

Drove global accountability and led cross-functional teams in pioneering the novel enterprise strategy, processes, and tools for Medical Device Regulations and Standards advocacy, monitoring, and assessment of impact.• Increased Core QMS compliance for global regulations and standards management by 60% by leading the development and implementation of the enterprise strategy, procedures, and tools.• Implemented a 21 CFR Part 11 compliant enterprise change management tool for Regulations and Standards Management with an 80% cost savings and only 10 weeks after project initiation.• Reduced Notified Body observations for the management of regulation and standard changes by 75% post process implementation.• Saved Central Regulatory Affairs $1.2m, 40% of spend, by optimizing compliance tools and subscriptions.• Built and led strong, diverse Central, Regional and Business Unit cross-functional teams to drive RA/QA internal/external strategy development, harmonization, and implementation.• Participated in AAMI Committee for Standards Strategy, AAMI QM WG (TAG to ISO/TC 210, and AdvaMed.

Led global cross-functional teams in aligning QMS process and tools to EU MDR/IVDR, analyzing gaps, performing risk assessments and defining remediation plans for associates worldwide.• Developed BD’s first policies for Combination Product Medical Device Reporting, PSUR, and PRRC.• Drove global compliance to EU MDR / IVDR by executing process and system improvements for Complaints, Internal Audit, Post Market Surveillance (PMS), Document Controls, CAPA, and Risk Management• Developed global communication plans and training for Quality Systems initiatives for worldwide audiences.

Led diverse teams in the creation, publication, and strategic implementation of global QMS compliance training.• Developed and implemented sustainable training programs for enterprise Quality System processes and tools for Complaints, PMS, Document Controls, CAPA, Technical Writing, and Risk Management• Performed gap assessments and developed mitigation plans for QMS process improvements worldwide.

Developed strategies for developing and implementing end user training for Global ERP Project.Mentored and trained the team of global trainers in execution of training in multiple regions and languages.

Verified IT Projects/Systems compliance to regulatory requirements and global SOX controls.Audited IT vendors to ensure compliance to 21 CFR Part 11 and international regulations.Delivered training on auditing Quality IT Systems for international compliance.Supervised team of six consultants.

Managed Developmental QA, Clinical Complaints and CAPA teams for clinical product development. Audited clinical manufacturing sites and packaging sites, per QSIT, to ensure compliance to GxP and drive manufacturing process improvements.Developed and executed internal auditor training program.

Team Lead for biopharmaceutical product complaints and internal audit. QA Lead for biopharmaceutical and solid oral dosage clinical trials and product development.• Led sterile biopharmaceutical product complaints and Post Market Surveillance (PMS) team. • Audited internal and vendor manufacturing and packaging sites to ensure supplier quality.• Performed mock Pre-Approval Inspections for FDA inspection readiness and trained internal auditors.• Wrote Field Alert Reports and chaired technical meetings for defect resolution.

Triaged Manufacturing and Laboratory Investigation Reportable Events.Led design, implementation, and system training of a Part 11 compliant paperless Investigation System.Developed and delivered training to manufacturing personnel on cGMPs and the TackWise Manufacturing Investigation System.

Edited the weekly publication and wrote the Flavors and Fragrance and Emerging Technologies columns.

Bachelor Of Science - Bs, Biochemistry

Bachelor Of Arts - Ba, Literature